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Allied Healthcare Group adds former CSL executive’s expertise to board

Mon, 21 May 2012 08:20:00 +1000

Allied Healthcare Group (ASX: AHZ) has appointed former CSL executive and general counsel Peter Turvey as a non-executive director.

Turvey worked at CSL, a biopharmaceutical company that develops and manufactures vaccines and plasma protein biotherapies, for 19 years.

He was initially appointed as the first corporate counsel before being appointed company secretary in 1998.

During his time at CSL, Turvey played a major role as part of the executive team that built CSL into the international company it is today.

He was also responsible for the management and licensing of CSL's intellectual property portfolio and overseeing risk management for the group.

Turvey was involved in many licensing deals, most notably the HPV vaccine Gardasil licence to Merck & Co., the licensing of the Iscomatrix® adjuvant platform technology to several of the world’s leading vaccine manufacturers, and establishment of the P.gingivalis vaccine technology collaboration between the CRC for Oral Health and Sanofi-Pasteur.

He is currently a principal at Foursight Associates and a non-executive director of listed biotechnology company Starpharma Holding, as well as a director of industry organisation Ausbiotech.

Turvey replaces Handojo (Jet) Soedirdja, who is retiring from the board.

Chris Catlow, chairman of Allied Healthcare Group, commented on the appointment:

“Peter’s experience building a global healthcare business as well has his licensing background will be a great benefit to the Allied Healthcare Group board.”

Allied recently increased its shareholding in investment company Coridon after investing a further A$1 million.

This is a strategic move for the company, giving Allied a 44.4% share in Coridon and maintaining its focus on unique drug programs with global implications.

Coridon is rapidly advancing towards its Phase I study for a herpes vaccine and is making further progress on its Human Papillomavirus (HPV) therapeutic vaccine program.

Less than two weeks prior to announcing it had increased its stake in Coridon, Allied Healthcare revealed Coridon had gained access to vector technology that will improve the performance of its next generation of DNA vaccines.

Coridon has entered into a licence agreement with Nature Technology Corporation for the use of its safe, minimalised and antibiotic-free selection vectors.

Proactive Investors is a market leader in the investment news space, providing ASX “Small and Mid-cap” company news, research reports, StockTube videos and One2One Investor Forums.

HealthLinx soon to begin sales of OvPlex™ in fast growing Indian market

Tue, 15 May 2012 11:00:00 +1000

HealthLinx’s (ASX: HTX) successful expansion of sales of its first-in-class ovarian cancer diagnostic test, OvPlex™, into the Singapore and Malaysian markets has prompted further expansion into other Asian markets.

OvPlex™ will hit the Indian market in the September quarter of 2012, with first sales to begin in Mumbai from August 1.

HealthLinx’s distribution partners, NEX Innovations Exchange and Metropolis Healthcare, will then ramp up expansion into all other major Indian cities in the following six months.

Indicating the market potential for OvPlex™, India is one of the world’s fastest growing and largest economies.

Sales in India are expected to rapidly increase over the next six months.

Nick Gatsios, HealthLinx managing director, commented:

“This expansion is an excellent result for women in India who will shortly have access to OvPlex™.

“As a company we are excited with INEX’s proactive expansion strategies and management of both companies is working very closely to ensure further expansion occurs in a seamless, cohesive and timely manner.”

Rapid expansion

OvPlex™ has been available in the Singapore and Malaysian markets since October 2010.

Since the start of sales in these markets, INEX has exceeded expected sales targets by around 25% with continued growth.

HealthLinx is ramping up global expansion and development of OvPlex™ following the signing of a four year funding agreement with La Jolla Cove Investors for up to US$9 million (A$8.5 million) in December 2011.

The funding will support HealthLinx’s push into key North American markets to supplement its existing sales jurisdictions of Australia, Singapore and the United Kingdom.

The company also plans to expand sales of OvPlex™ into other jurisdictions in which INEX has an option under the distribution agreement, including Indonesia and Thailand.

OvPlex™

OvPlex™ is a diagnostic test that measures levels of five proteins in a patient’s blood. One of the proteins is CA125, which has been used for several years for the detection and monitoring of ovarian cancer.

The ovarian cancer market is estimated to be around US$270 million per annum.

Proactive Investors is a market leader in the investment news space, providing ASX “Small and Mid-cap” company news, research reports, StockTube videos and One2One Investor Forums.

pSivida Corporation nears sales of ILUVIEN® in the U.K. with granting of marketing approval

Tue, 08 May 2012 10:00:00 +1000

pSivida Corporation (ASX: PVA, NASDAQ: PSDV) has been granted marketing authorisation in the U.K. for its ILUVIEN® product for the treatment of vision impairment associated with chronic diabetic macular edema (DME).

This latest approval follows close on the heels of the granting of marketing authorisation in Austria late last month.

ILUVIEN® is expected to be the first sustained release pharmaceutical in the European Union to treat diabetic macular edema.

Highlighting the market potential, Alimera Sciences, licensee of the ILUVIEN® product, estimates that nearly 200,000 of the 3 million people currently living with diabetes in the U.K. suffer with vision loss from DME.

In late February, pSivida announced the decentralised procedure for the approval of ILUVIEN® in Europe.

Importantly, the Reference Member State, the Medicines and Healthcare products Regulatory Agency of the United Kingdom, and the Concerned Member States (CMS) have all deemed that ILUVIEN® is approvable.

pSivida has shrugged off some of the negative market sentiment it has been experiencing in recent times.

Shares hit an intra-day high of A$2.42 the day after the company received Austrian approval for ILUVIEN® in late April, marking a 133% increase over its lowest point for the 2012 calendar year of $1.04 on the last day of January.

Shares have since settled back to $2.10 as of close of trade yesterday, still a 102% increase over the start of the year.

Proactive Investors is a market leader in the investment news space, providing ASX “Small and Mid-cap” company news, research reports, StockTube videos and One2One Investor Forums.

Allied Healthcare Group substantial shareholder The Metal Group moves to 17.84% interest

Wed, 02 May 2012 08:10:00 +1000

Allied Healthcare Group (ASX: AHZ) substantial shareholder The Metal Group has increased its stake in the company to 17.84%.

The Metal Group acquired around 34.3 million additional shares at $0.028 per share for a total consideration of $959,760 on 27 April.

The purchase increased the investor’s stake by 3.15%.

Highlighting the rapid pace at which Allied Healthcare continues to meet milestones, the company recently increased its shareholding in Coridon after investing a further A$1 million.

This is a strategic move for Allied Healthcare, giving the company a 44.4% share in Coridon and maintaining its focus on unique drug programs with global implications.

Coridon is rapidly advancing towards its Phase I study for a herpes vaccine and is making further progress on its Human Papillomavirus (HPV) therapeutic vaccine program.

Less than two weeks prior to announcing it had increased its stake in Coridon, Allied Healthcare revealed Coridon had gained access to vector technology that will improve the performance of its next generation of DNA vaccines.

Coridon has entered into a licence agreement with Nature Technology Corporation for the use of its safe, minimalised and antibiotic-free selection vectors.

Importantly, the use of this vector will improve the overall benefit of Coridon’s vaccine by driving the in vivo transcription and translation of the genetic material.

Allied Healthcare is also further proving the commercial benefits of its ADAPT® Tissue Engineering Process.

In early April the company released positive 36-month post Phase II human clinical trial follow-up results of paediatric patients who were implanted with the CardioCel® cardiovascular patches during various corrective cardiac surgical procedures.

CardioCel® is a collagenous-based bioprosthetic device, made of tissue derived from bovine pericardium and treated with the ADAPT® Tissue Engineering Process.

The follow up data further supports the data for subsidiary Celxcel’s technology, in particular the prevention of calcium build up in tissue post implantation.

Proactive Investors is a market leader in the investment news space, providing ASX “Small and Mid-cap” company news, research reports, StockTube videos and One2One Investor Forums.

Allied Healthcare Group increases stake in Coridon to 44%

Fri, 27 Apr 2012 09:30:00 +1000

Allied Healthcare Group (ASX: AHZ) has increased its shareholding in Coridon after investing a further A$1 million.

This is a strategic move for Allied Healthcare, giving the company a 44.4% share in Coridon and maintaining its focus on unique drug programs with global implications.

Coridon is rapidly advancing towards its Phase I study for a herpes vaccine and is making further progress on its Human Papillomavirus (HPV) therapeutic vaccine program.

Lee Rodne, Allied Healthcare Group managing director, said, “Our investment is timed as Coridon progresses its development programs.

“We will continue to increase this holding as Coridon pushes towards its Phase I trial and beyond – as outlined during the recent capital raising.”

Allied Healthcare received strong investor support for its recent capital raising, netting a further A$2 million.

This represents a take-up of over 40% of the rights issue and, importantly, Allied Healthcare has received strong interest in taking up the shortfall to raise the full $4.36 million.

This latest equity raising is in addition to $2 million raised in mid-March.

Importantly, the capital raising places Allied Healthcare in a strong financial position and removes concerns about future funding.

The remaining funding will be used to assist Coridon in progressing its vaccine programs.

Coridon successfully completed pre-clinical efficacy testing of its HSV-2 herpes vaccine in October last year and is nearing clinical studies.

The company tested a number of different formulations of the vaccine which proved 100% effective at protecting animals against HSV-2 infection.

Meanwhile, Coridon’s next generation therapeutic Human Papillomavirus (HPV) vaccine is targeting one of the most common sexually transmitted diseases in the world.

HPV is associated with several human cancers, most notably cervical cancer.

To give an indication of the revenue potential of a HPV vaccine, the two currently used vaccines generate in excess of $1.5 billion in sales annually.

Coridon’s HPV vaccine has been designed to combat existing infection with the HPV virus, to prevent and treat cervical and other HPV-associated cancers.

The development program is based on preliminary work by Coridon founder Professor Ian Frazer’s team and follows on from Frazer’s work that resulted in the successful cervical cancer preventative vaccines – Gardasil®, marketed by Merck, and Cervarix, marketed by GlaxoSmithKline.

Proactive Investors is a market leader in the investment news space, providing ASX “Small and Mid-cap” company news, research reports, StockTube videos and One2One Investor Forums.

Allied Healthcare Group well supported by market, raises $2m to increase Coridon ownership

Thu, 26 Apr 2012 08:23:00 +1000

Allied Healthcare Group’s recent capital raising will allow the company to increase its ownership in investment company Coridon. Lee Rodne, chief executive officer, said the equity raising removes any concerns about future funding for the company.

pSivida Corporation regains market attention, shares soar 102% since January

Wed, 18 Apr 2012 16:10:00 +1000

pSivida Corporation (ASX: PVA, NASDAQ: PSDV) has shrugged off some of the negative market sentiment it has been experiencing in recent times with shares rallying 102% since the end of January.

The company reached an intra-day high of $2.10 today, compared to its lowest point for the 2012 calendar year of $1.04 on the last day of January.

Last month pSivida entered its second partnership to assess its Durasert™ drug delivery technology in ophthalmology.

pSivida and U.S.-based ocular drug development company Neuron Systems are evaluating the use of pSivida’s technology as a delivery system for the treatment of dry age related macular degeneration (Dry AMD), a serious retinal disease that afflicts millions of patients worldwide and can lead to blindness.

In November the company signed a funded technology evaluation agreement with a leading global pharmaceutical company.

Durasert™ is a fully bioerodible implantable delivery device system that is small enough to fit inside the barrel of a 25 gauge needle.

pSivida is using the technology to develop a long term sustained release implant of latanoprost, the most commonly prescribed agent for ocular hypertension and glaucoma.

The product candidate is designed to be administered by an eye care professional into the subconjunctival space of the eye in a minimally invasive procedure.

Meanwhile, pSivida’s ILUVIEN® product is expected to be the first sustained release pharmaceutical in the European Union to treat diabetic macular edema.

In late February, the company announced the decentralised procedure for the approval of ILUVIEN® in Europe.

Importantly, the Reference Member State, the Medicines and Healthcare products Regulatory Agency of the United Kingdom, and the Concerned Member States (CMS) have all deemed that ILUVIEN® is approvable.

The regulatory process has advanced to the national phase of the decentralised procedure in which the Reference Member State and each Concerned Member State will grant its national licence.

Proactive Investors is a market leader in the investment news space, providing ASX “Small and Mid-cap” company news, research reports, StockTube videos and One2One Investor Forums.

Allied Healthcare Group: Coridon secures licence to vector technology

Tue, 17 Apr 2012 09:20:00 +1000

Allied Healthcare Group’s (ASX: AHZ) investment company Coridon has gained access to vector technology that will improve the performance of its next generation of DNA vaccines.

Coridon has entered into a licence agreement with Nature Technology Corporation for the use of its safe, minimalised and antibiotic-free selection vectors.

Importantly, the use of this vector will improve the overall benefit of Coridon’s vaccine by driving the in vivo transcription and translation of the genetic material.

“Access to this technology will allow the Coridon vaccine to fully maximise its gene expression and therefore improve the performance of the vaccine,” Lee Rodne, chief executive officer of Allied Healthcare Group, said.

“These are important steps forward to the initial Phase I study for Coridon which will provide validation of the Coridon technology.”

The licensing agreement with Nature Technology Corporation also allows Coridon access to the HyperGRO fermentation technology, which provides for high yield and cost effective DNA production.

Phase I trial

Coridon’s Herpes vaccine, which was recently announced to be 100% effective in protecting animals against Herpes Simplex Virus 2 infection, incorporates the NTC8485 antibiotic-free expression vector.

Nature Technology Corporation’s vectors have been designed to comply with U.S. Food and Drug Administration and European Medicines Agency regulatory guidance.

Coridon’s HPV vaccine has been developed to combat existing infection with the HPV virus, to prevent and treat cervical and other HPV-associated cancers.

Cervical cancer is the second largest cause of cancer deaths in women worldwide. Globally, this equates to 510,000 cases per year, and about 288,000 deaths, according to the World Health Organization.

In the U.S. alone, about $1.7 billion is spent each year to treat cervical cancer.

To give an indication of the revenue potential of a HPV vaccine, the two currently used vaccines generate in excess of $1.5 billion in sales annually.

A Phase I study for Coridon’s herpes vaccine is scheduled to begin later this year.

U.S. manufacturing

Coridon has contracted a U.S. facility to manufacture its Phase I vaccine. VXGI Inc has begun manufacturing the Herpes vaccine using the HyperGRO technology.

ASX healthcare companies buck downward momentum: PharmAust, CBio, Immuron

Mon, 16 Apr 2012 18:00:00 +1000

Some small to mid-cap healthcare stocks managed to shrug off the downward pull of the broader Australian market by the closing bell today.

Renewed volatility in international markets last week has brought the Australian market down today, with the ASX All Ordinaries closing down 0.5%, or 21.4 points, at 4,382.8 points.

The healthcare sector as a whole was unable to escape the plunge, wiping off 0.4%, or 37.3 points, to finish at 8,746 points for the day.

However, some investor support for the small to mid-caps remained with pharmaceutical company PharmAust (ASX: PAA) one of the upwards movers with an 8.3% gain to A$0.013.

CBio (ASX: CBZ) rose 7.7% to $0.07 today, while genetic testing business Genetic Technologies (ASX: GTG) made modest gains of 6.7% to $0.095.

Circadian Technologies (ASX: CIR) advanced 6.1% to $0.52 followed by oral immunotherapy specialist Immuron (ASX: IMC), which jumped 4% to $0.03.

Joining the gainers were also heart device developer Sunshine Heart (ASX: SHC) with a rise of 3.5% to $0.03 and bioimpedance device developer ImpediMed (ASX: IPD) on a slight move upwards of 2.4% to $0.43.

Many of the other small to mid-cap healthcare stocks remained unchanged with the exception of neurological specialist Prana Biotechnology (ASX: PBT), magnetic drug delivery company OBJ (ASX: OBJ) and biomedical research company Biotron (ASX: BIT), which all finished the day down.

Allied Healthcare Group further proves up commercial benefits of tissue technology

Thu, 05 Apr 2012 10:00:00 +1000

Allied Healthcare Group (ASX: AHZ) has released positive 36-month post Phase II human clinical trial follow-up results of paediatric patients who were implanted with the CardioCel® cardiovascular patches during various corrective cardiac surgical procedures.

Lee Rodne, managing director, said the follow up data further supports the data for subsidiary Celxcel’s technology, in particular the prevention of calcium build up in tissue post implantation.

“This is a major market differentiator for products using the technology and provides major benefit for patients longer term,” he said.

Calcification of tissue heart valves shortens the lifespan of implanted tissue. This often results in clinicians choosing to use mechanical valves, which requires patients to undergo lifelong and complicated anticoagulant therapy.

Rodne previously told Proactive Investors currently the build-up of calcification means that implanted heart valve tissue has a shorter lifespan of around 10 years when compared to mechanical valves which is over 20 years.

CardioCel® is a collagenous-based bioprosthetic device, made of tissue derived from bovine pericardium and treated with Celxcel’s ADAPT® Tissue Engineering Process.

In May 2008, 30 patients aged 3 months to 14 years were implanted with the CardioCel® patches.

The study included paediatric patients diagnosed with congenital heart disease that required a tissue patch for corrective surgical repairs during major open-heart surgery.

The follow up program followed selected patients to evaluate over a three year period. To date 14 patients have been followed up after two years and five patients have reached three year follow up points.

Importantly, all patients were free of patch-related complications or adverse events.

Echocardiographic (heart ultrasound) results showed intact haemodynamics (blood flow) with no evidence of significant calcification of the CardioCel® patch at the 24 and 36-month evaluation.

Celxcel will now review all patients in the Phase II study to gain additional long-term data.

Commercial Discussions

Following earlier positive trial results Allied Healthcare Group began discussions on partnering and commercial distribution opportunities for CardioCel®.

CardioCel®is set for Therapeutic Goods Administration audit, approval and launch in 2012. The product is now going through the regulatory approval process in Australia, and this may lead to near-term revenues in the local market as early as 2012-13.

Allied Healthcare Group advances towards clinical trials of ADAPT® technology with further success

Thu, 29 Mar 2012 09:35:00 +1100

Positive results from a successful implant of Allied Healthcare Group’s ADAPT®-treated patch during pelvic floor and hernia reconstruction procedures paves the way for a supporting clinical trial and commercial discussions.

Allied Healthcare Group granted Singapore patent, boosts commercial prospects for ADAPT®

Mon, 19 Mar 2012 09:30:00 +1100

Allied Healthcare Group’s (ASX: AHZ) subsidiary Celxcel has improved the commercial prospects of its ADAPT®-Tissue Engineering Process (TEP) with the successful granting of a patent covering the technology in Singapore.

Celxcel chief executive officer Bob Atwill said, “The Celxcel technology has a robust patent position around our current platform technology (ADAPT®-TEP) and we continue to pursue filings to cover our future portfolio of products.”

ADAPT®-TEP is a technology platform which has been used across a number of tissue types for use in cardiovascular, pelvic floor reconstructions and hernia repair applications.

Celxcel is also evaluating how the process can be used in orthopaedics and as a biological scaffold to grow and deliver stem cells.

The company has received patents in a number of key jurisdictions already including Australia, New Zealand and China.

Celxcel also has a number of patent applications in the pipeline in other key jurisdictions, including the U.S., Europe, Japan, Israel and Canada.

Highlighting the substantial progress Celxcel is making with its ADAPT®-TEP technology, the company successfully implanted its cardiovascular patch CardioCel® during a double valve leaflet reconstruction earlier this month.

Importantly, normal valve function was regained after these reconstructions and all animals survived the open-heart surgical procedures without any adverse effects or immediate complications.

Allied Healthcare Group managing director Lee Rodne told Proactive Investors previously that in the U.S. alone, the cardiovascular tissue space generates around US$700 million in revenues and is growing.

“We don’t need to capture all of that market share to have significant revenue,” he said.

The successful valve reconstruction demonstrates the wider applications of its ADAPT®-TEP technology.

“This technology has the potential to change the way paediatric surgeons approach individualised reconstructions of deformed or damaged heart valves using our technology,” Rodne said.

“Positive results will also open up further commercial discussions on the potential applications for CardioCel®.”

Allied Healthcare’s Growth

Allied Healthcare is on the cusp of building a global healthcare company. The company has expanding revenues, with the objective to increase this to $20-30 million within two to three years via organic growth and acquisitions.

The regenerative medicine market is currently around $3 billion and growing. Allied Healthcare has the upper hand, because at present there is no similar product available to surgeons on the market.

The initial application for the CardioCel® patch is congenital heart disease. About eight in 1,000 children are born with the disease and around half of them have surgery. This presents an extensive global market potential for the technology.

Celxcel is targeting the filing for approval of CardioCel® in various markets and the initial market launch in 2012-13.

Allied Healthcare Group to boost kitty by A$6.36m to advance Coridon vaccines

Fri, 16 Mar 2012 10:00:00 +1100

Allied Healthcare Group (ASX: AHZ) is undertaking an equity raising of up to A$6.36 million to progress investment company Coridon’s Herpes Simplex Virus 2 (HSV-2) vaccine program.

Indicating the strong investor backing the company has, a commitment of $2 million has already been achieved for a placement that was oversubscribed.

The placement will comprise the issue of around 66.7 million shares at $0.03 each to institutional and professional investors.

Allied Healthcare will also undertake a one for five non-renounceable rights issue, also at $0.03 each, to eligible shareholders to raise the remaining $4.36 million.

Allied Healthcare Group chief executive officer Lee Rodne said the key benefit of having additional capital is that the company will be able to push forward its near term and most promising projects.

“This will allow us to take them to the next phase of development and also help in generating shareholder returns in the immediate future,” he said.

The company is a major shareholder in Coridon, which is advancing its HSV-2 vaccine towards clinical studies after successfully completing pre-clinical efficacy testing in October last year.

Coridon tested a number of different formulations of the vaccine which proved 100% effective at protecting animals against HSV-2 infection.

The equity raising will also assist the company in accelerating Coridon’s next generation therapeutic Human Papillomavirus (HPV) vaccine targeting one of the most common sexually transmitted diseases in the world.

HPV is associated with several human cancers, most notably cervical cancer.

To give an indication of the revenue potential of a HPV vaccine, the two currently used vaccines generate in excess of $1.5 billion in sales annually.

Coridon’s HPV vaccine has been designed to combat existing infection with the HPV virus, to prevent and treat cervical and other HPV-associated cancers.

The development program will be based on preliminary work by Coridon founder Professor Ian Frazer’s team and follows on from Frazer’s work that resulted in the successful cervical cancer preventative vaccines – Gardasil®, marketed by Merck, and Cervarix, marketed by GlaxoSmithKline.

Allied Healthcare is also targeting regulatory approval of Celxcel’s CardioCel® cardiovascular patch and the funds raised will provide greater resources to achieve that.

CardioCel®, which uses Celxcel’s ADAPT® Tissue engineering technology, is used to treat heart deformities caused by congenital heart disease, and for heart valve repair and reconstructions.

CardioCel® is scheduled for initial marketing approval towards the end of 2012.

pSivida Corporation enters second partnership to assess drug delivery technology for eye diseases

Wed, 14 Mar 2012 14:20:00 +1100

pSivida Corporation (ASX: PVA, NASDAQ: PSDV) will evaluate the use of its Durasert™ drug delivery technology in ophthalmology in partnership with U.S.-based ocular drug development company Neuron Systems.

The two companies entered an agreement to assess the use of pSivida’s technology as a delivery system for the treatment of dry age related macular degeneration (Dry AMD), a serious retinal disease that afflicts millions of patients worldwide and can lead to blindness.

There is currently no treatment on the market for Dry AMD, which affects more people than Wet AMD, a condition that affects less than 20% of the population with AMD and is well treated with products such as Genentech’s billion dollar Lucentis and Regeneron’s Eylea.

This is the second technology evaluation agreement pSivida has signed for its bioerodible Durasert technology since the company regained the rights to its intellectual property from Pfizer last year.

In November the company signed a funded technology evaluation agreement with a leading global pharmaceutical company.

Durasert™ is a fully bioerodible implantable delivery device system that is small enough to fit inside the barrel of a 25 gauge needle.

pSivida is using the technology to develop a long term sustained release implant of latanoprost, the most commonly prescribed agent for ocular hypertension and glaucoma.

Allied Healthcare Group soon to release capital raising announcement, granted halt

Wed, 14 Mar 2012 09:40:00 +1100

Allied Healthcare Group (ASX: AHZ) has been granted a trading halt by the ASX today as it prepares to release an announcement to the market regarding a capital raising, with the company in pre-open.

The company’s tissue engineering and regenerative medicine division Celxcel has been busy confirming the broader applications of its CardioCel® cardiovascular patch.

Celxcel has successfully implanted the patch during a double valve leaflet reconstruction.

Importantly, positive results in the study opens up further commercial discussion opportunities for Allied Healthcare Group and Celxcel on the potential applications of CardioCel®.

The halt will last until the earlier of an announcement being made available to the market, or the opening of trade on Friday 16 February.

Allied Healthcare Group successfully implants cardiovascular patch for valve reconstruction

Tue, 13 Mar 2012 09:44:00 +1100

The successful implantation of CardioCel® to repair heart valves confirms the cardiovascular patch’s wider use, as well as opens up further commercial discussion opportunities for Allied Healthcare Group on the potential applications.

Allied Healthcare Group advances regulatory approval

Mon, 05 Mar 2012 17:00:00 +1100

Allied Healthcare Group’s (ASX: AHZ) tissue engineering and regenerative medicine division Celxcel is progressing its regulatory strategy for bringing products to market, which it anticipates will accelerate the approval process for its tissue engineering process ADAPT®.

Under this new strategy, Celxcel is confident of obtaining market authorisations in 2012 and 2013 to market CardioCel, a cardiovascular patch to treat congenital heart disease, and other ADAPT® treated products, according to Allied Healthcare Group managing director Lee Rodne.

“With a focus on delivering shareholder returns as well as therapeutic value, our strategy is to get products to market as soon as we can, while at the same time looking at broader applications for future market opportunity,” he said.

Regulatory Approval Progress – Australia, Europe, U.S.

Celxcel has received confirmation from the Therapeutic Goods Administration (TGA) that its CardioCel® cardiovascular patch has been successful in the pre-assessment of the submission.

The company’s submission is now progressing through the conformity assessment evaluation process for the Australian market.

Discussions with opinion leaders on Celxcel’s Advisory Board regarding use of CardioCel® prior to TGA approval in clinical trials and other pre-market access routes are also advancing.

Based on the current progress and interaction, the company expects approval for the program at the end of 2012.

Meanwhile, Celxcel has begun discussions with SGS, an international third party assessment organisation who can act as the company’s Notified Body for European CE Marking.

SGS is also able to assist in obtaining Canadian Marketing Authorisation, in addition to other countries such as Taiwan and Hong Kong.

Celxcel is investigating which other markets it will gain access to outside of Europe by obtaining CE Mark.

The company is also planning a filing for U.S. approval and is investigating, in conjunction with a global contract research organisation and regulatory consulting group, the best approach for U.S. submission.

Celxcel CEO Bob Atwill said, “The ADAPT®-treated patch has over the past decade been successfully tested in a number of in-vitro, in-vivo models and a Phase II clinical trial setting to assess the durability, biocompatibility and calcification potential of the implant.

“We are pleased to be on the threshold of the first product from this platform technology being launched into the cardiovascular marketplace.”

Broader Applications for ADAPT®

In addition to the initial cardiovascular products, Celxcel is also evaluating how the process can be used in pelvic floor reconstructions, hernia repair, orthopaedics and as a biological scaffold to grow and deliver stem cells.

In December 2011, Celxcel delivered positive results from a tissue heart valve study of its ADAPT® technology that show a reduction in visible calcification of implanted tissue heart valves.

Importantly, this opens up the possibility of extending the lifespan of implanted tissue valves dramatically.

Currently, a build-up of calcification means that implanted heart valve tissue has a shorter lifespan of around 10 years when compared to mechanical valves which is over 20 years.

The Tissue Heart Valve Study compared the performance (biocompatibility and calcification potential) of the heart valve tissue, treated with the ADAPT anti‐cytotoxic and anti‐calcification process, plus Celxcel’s terminal sterilisation method.

The tissue subjected to Celxcel’s terminal sterilisation method showed significantly reduced levels of calcification, while the tissue subjected to the ADAPT anti‐calcification engineering process, plus the terminal sterilisation method demonstrated the lowest levels of calcification during the entire study.

Calcification of tissue heart valves shortens the lifespan of implanted tissue. This often results in clinicians choosing to use mechanical valves, which requires patients to undergo lifelong and complicated anticoagulant therapy.

Following the positive study results, Celxcel entered into discussions on partnering and commercial distribution opportunities for CardioCel.

Allied Healthcare Group: Coridon targets $1.5b HPV market, developing next generation vaccine

Tue, 28 Feb 2012 10:47:00 +1100

A new next generation therapeutic Human Papillomavirus vaccine being developed by Coridon, a company which Allied Healthcare Group is a major shareholder in, has revenue potential of in excess of $1.5b annually.

pSivida Corporation shares up 11.54%, CEO takes seat on international glaucoma panel

Fri, 03 Feb 2012 15:40:00 +1100

pSivida Corporation (ASX: PVA) is attracting some investor interest today, with shares jumping 11.54% to A$1.16 at 2.38pm (AEDT).

The company announced today president and chief executive officer Paul Ashton will participate in a panel, New Horizons in Glaucoma Drug Delivery and IOP Monitoring, during the Glaucoma 360 New Horizons forum on Friday 3 February at the Palace Hotel in San Francisco.

pSivida is developing a product to treat glaucoma and occular hypertention in collaboration with Pfizer.

Durasert™ is a fully bioerodible implantable delivery device system that is small enough to fit inside the barrel of a 25 gauge needle.

pSivida is using the technology to develop a long term sustained release implant of latanoprost, the most commonly prescribed agent for ocular hypertension and glaucoma.

The product candidate is designed to be administered by an eye care professional into the subconjunctival space of the eye in a minimally invasive procedure.

Allied Healthcare Group: Dr Julian Chick to fill the chief operating officer’s seat

Wed, 07 Dec 2011 16:32:00 +1100

Allied Healthcare Group (ASX: AHZ) has welcomed Dr Julian Chick to the executive team as chief operating officer to help drive the commercialisation of the company’s product pipeline and develop further commercial opportunities for the group.

Chick has spent the last 10 years in the biotechnology sector, most recently building up a successful contract research and corporate advisory business at JDJ Bioservices, and prior to that was an executive at Avexa and Amrad.

He is also a non-executive director of the industry body BioMelbourne Network.

Chick, who is scheduled to begin his new role in the New Year, will retain his position as non-executive director of Coridon – the DNA vaccine development company led by Professor Ian Frazer, and part of the Allied Group.

Managing director Lee Rodne said, “We are very excited to have the experience and industry knowledge that Dr Chick will bring to our executive team.”

“He joins us at an important time and will play a key role in developing further commercial opportunities for the Allied Group.”

Chick will focus on the operational side of the business as well as exploring M&A and business development opportunities that will help build the Allied business.

Allied has begun discussions on partnering and commercial distribution opportunities for subsidiary Celxcel’s lead product CardioCel.

The company has also had recent success in a tissue heart valve study of its ADAPT® Tissue Engineering technology which has demonstrated a reduction in visible calcification of implanted tissue heart valves.

The ADAPT® Tissue Engineering technology could extend the lifespan of implanted tissue beyond its current 10 years.

Allied Healthcare Group technology could extend implanted tissue lifespan, in distribution talks

Mon, 05 Dec 2011 09:30:00 +1100

Following further success in demonstrating a reduction in the calcification of implanted tissue, this time in heart valve tissue, Allied Healthcare Group has started discussions on partnering and commercial distribution opportunities for subsidiary Celxcel’s lead product CardioCel.

Allied Healthcare Group: Broker places "Speculative Buy," $0.10 price target

Thu, 01 Dec 2011 15:16:00 +1100

Western Australian-based healthcare company Allied Healthcare Group has received a Speculative Buy recommendation at a price target of $0.10 per share, over double its current share price of $0.04.

Allied Healthcare Group appoints key executive to biotechnology company, Celxcel

Tue, 22 Nov 2011 08:35:00 +1100

The Biotechology division of Allied Healthcare is on the move with a key appointment of Bob Atwill to drive Celxcel's lead product CardioCel, which is set for TGA audit, approval and launch in 2012. CardioCel is going through the regulatory approval process in Australia, and this could lead to near-term revenues in the local market as early as 2012/13.

Allied Healthcare Group on the cusp of building a global healthcare company

Fri, 18 Nov 2011 11:18:00 +1100

There is a sense of quality and potential at the Allied Healthcare. Backed by Fortescue Metals Group key executives, strong management, revenues from medical devices and clinical development partnerships - current valuation of $20m – looks unlikely to be on offer for too long given upcoming catalysts.

Holista CollTech signs health food R&D agreement with Red Rooster operator

Tue, 08 Nov 2011 11:31:00 +1100

Holista CollTech (ASX: HCT) has signed an exclusive two year research and development agreement with Quick Service Restaurant Holdings to develop healthier food without using chemical additives.

Under the agreement, Holista will supply its proprietary ingredients to Quick Service for joint research and development, with the aim of integrating Holista’s technology into Quick Service’s product pipeline.

Quick Service is the operator of the brands Red Rooster, Chicken Treat and Oporto.

The collaboration covers three patents; a potato chip that absorbs less fat during frying, a low-sodium salt and a low GI bread that digests and absorbs carbohydrates slowly, while releasing glucose more gradually into the bloodstream.

Holista will supply the natural ingredients for the three formulations, all of which are Asian ingredients listed by Australia’s Therapeutic Goods Administration and the United States Food and Drug Administration as “Generally regarded as safe”.

The company conducted initial research on the ingredients in the United Kingdom, India and Malaysia, and undertook validation at the University of Western Australia as part of the commercialisation project.

Holista will be responsible for all costs of research and development, which is currently expected to be about $820,000.

The company will receive milestone payments from Quick Service for a portion of these costs, and will seek research and development grants to assist in funding the costs.

The two companies have also agreed to a preferential supply arrangement for a further five years beyond the initial two year exclusivity agreement.

Holista is a biotechnology food ingredient specialist with operations in Australia and Asia.

Under the agreement, Holista will not sell its ingredients or products to any competitor of Quick Service within the Australian market.

IntelliCell jumps over 21% on exclusive sale and supply agreement with Millipore

Wed, 28 Sep 2011 02:26:00 +1000

IntelliCell BioSciences (OTCQB:SVFC) said Monday that it has inked an exclusive agreement with Millipore Corporation to supply and sell Millipore's guava flow cytometry platform, used for the manufacturing of stromal vascular fraction (SVF) containing adipose-derived adult stem cells.

The use of autologous adipose, or fat stem cells for a growing variety of indications is a new and exciting frontier in medicine. Since the middle of 2009 when the U.S. FDA published its laws on autologous stem cells, the field has expanded rapidly.

Currently, numerous doctors are studying the use of these cells for aesthetics, the treatment of arthritis, and several orthopedic injuries such as knees, elbows, back, and shoulders, as well as more serious ailments like heart disease.

The collaboration between the two companies is expected to streamline the development of IntelliCell's tissue processing centres throughout the US, as it continues to expand amid increasing demand for the cells it sources from fatty tissue. The centres receive and employ the IntelliCell process to the adipose stromal vascular fraction harvested by physicians in their own offices, and then return the IntelliCells to the physicians the same day.

The company has already established processing centers in Baton Rouge, New York City, Philadelphia, Dallas/Ft. Worth, Denver, Houston, New Orleans, Orlando, and West Palm Beach.

"This is a phenomenal step in the right direction for our company and we welcome the opportunity to work with Millipore," said IntelliCell chairman and CEO, Dr. Steven Victor.

"The exclusive agreement with Millipore to supply and sell their cutting-edge guava flow cytometer, combined with our proprietary process which has achieved unprecedented yields of stromal vascular fraction without the use of chemical additives such as enzymes, gives us a highly significant advantage in creating the gold standard for the separation of SVF from fat."

"As the only company to use precise methods of counting cells and checking specimens for cell viability, dead cells, or debris, this is yet another milestone in our quest to become market leader in the area of separation of SVF, which greatly differentiates us from all other companies that manufacture these cells."

Shares of IntelliCell soared over 21%, to close at $3.95 on Monday.

IntelliCell inks licensing deal with pet company Paws

Wed, 07 Sep 2011 23:29:00 +1000

IntelliCell BioSciences (OTC:SVFC) said on Tuesday it has signed a licensing deal with pet services company Paws (OTC:PAWS), set to boost IntelliCell’s presence in the pet industry.

IntelliCell, through its proprietary technology, processes stromal vascular fraction stem cells, derived from people’s body fat.

Fat stem cells are cutting edge, with many practitioners and companies researching the use of them for anti-aging effects, as well as for the treatment of more serious conditions like arthritis, congestive heart failure, gum recession, and wound healing.

Since the middle of 2009 when the U.S. Food and Drug Administration published its laws on autologous stem cells, the field has expanded rapidly.

Numerous studies have also been conducted on animals for veterinary applications over the last few decades.

The collaboration between IntelliCell and Paws will make fat-derived stem cells available to the veterinary world for use in a full-spectrum of pet applications.

"Our deal with The PAWS Pet Company is a very exciting advancement for veterinary medicine. With their marketing skills in the animal world and our advanced technology we have a winning formula for treating animals with 'IntelliCells' which has a high concentration of stem cells," Steven Victor, CEO of IntelliCell, said in a statement.

PAWS CEO, Dan Wiesel, added: "We are excited to be working with IntelliCell to bring their regenerative medicine treatment to the pet marketplace.

"Through our trusted position with both Pet Parents and Veterinarians, we will introduce a technology that we believe will improve the wellbeing of pets."

IntelliCell’s adipose stem cell processing technique takes about 30 minutes and the stem cells can be returned to the veterinarian in the same day.

The New York-based company has processing centers in New York City, Philadelphia, Dallas, and New Orleans.

IntelliCell's fat-derived stem cells termed "technological breakthrough" in Forbes

Tue, 30 Aug 2011 06:08:00 +1000

IntelliCell BioSciences (OTCBB:SVFC) has made a technological breakthrough into the regenerative medicine field, according to blog entry in Forbes.

The company, through its proprietary technology, processes stromal vascular fraction (SVF) stem cells, derived from one's own body fat.

Fat stem cells are now the cutting edge, with many doctors and companies researching the use of them for anti-aging effects, as well as for the treatment of more serious conditions like arthritis, congestive heart failure, gum recession, and wound healing.

IntelliCell's SVF cells can be used to treat certain conditions, or rejuvinate damaged tissue and cell function. The company, which under the FDA is authorized to commercially sell its SVF cells, has also applied for a patent on its use of ultrasonic cavitations to break up fat cells, which increases the number of SVF stem cells that can be extracted from just two ounces of fat to between 500 million and 1.4 billion, Forbes said.

The company's technique takes approximately 30 minutes, costs less than other stem cell extraction products, and the stem cells can be returned to a patient’s doctor in the same day.

"It is very apparent that a person’s fat cells are the best source of stem cells, which are stored inactively in one’s fat tissues, for use in the fast growing field of regenerative medicine," IntelliCell CEO, Dr. Steven Victor told Forbes.

Forbes noted that IntelliCell's technology can produce an average of 10 times the number of stem cell-containing SVF cells as traditional methods, which require the use of enzymes, according to a study of the company's technology by a unit of Merck AG.

Indeed, these fat stem cells have similar potential to embryonic stem cells in their pluripotency, and are from a source that involves no moral or ethical issues, as well as no chemical additives required for digestion of the tissue.

In the aesthetic world, the use of autologous adipose, or fat, stem cells has become widely accepted in Europe and Asia. Since the US FDA published its laws on autologous stem cells in mid-2009, the field has expanded rapidly.

IntelliCell has also treated more than 100 patients this year alone, Forbes said, including the wife and daughter of MAZ Capital Advisors' president, and IntelliCell shareholder, Walter Schenker. Each underwent a successful treatment at an IntelliCell lab for knee ailments, Forbes cited.

IntelliCell, whose shares on the OTC were trading at $3.95 on Monday, has established processing centers in New York City, Philadelphia, Dallas/Ft. Worth, and New Orleans, and has entered into licensing agreements for centers in Houston and Palm Beach.