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Allied Healthcare Group shares ride high on back of strong prospects for its CardioCel product

Mon, 20 May 2013 17:05:00 +1000

Allied Healthcare Group (ASX:AHZ) shares jumped over 12% today as the market continued to recognise the prospects for its CardioCel product for the treatment of congenital heart disease and value within the group.

The shares have gained almost 18% in the last five trading sessions and has gone up to $0.045 today compared with $0.02 in early January this year.

The company currently has revenue from Allied Medical, which sells medical equipment in Australasia and revenue is growing.

At the time of its latest quarterly, it generated over $5.4M in revenue to date this financial year, up 8% for the year to date and indicating continued strong growth in revenue.

During the quarter Allied also filed its 510(K) marketing approval submission with the U.S Food and Drug Administration for CardioCel heart patch.

CardioCel continues to be used in patients to treat and repair congenital heart defects via the Authorised Prescriber Scheme in Australia.

Also, surgeons based in Melbourne and Brisbane have now been approved to use CardioCel in patients. This was supported by additional data from the Phase II extension study which showed patients progressing well 4 years after receiving CardioCel, with these patients showing no signs of calcification, a unique feature of the CardioCel product.

Allied is expecting additional early access approvals at key centres in Australia and full regulatory approval of CardioCel in at least one jurisdiction this year.

Over the last quarter Allied also announced positive results from its regenerative tissue franchise in the areas of hernia repair, pelvic floor repair and stem cell seeding.

These results complement the existing work with CardioCel and show the potential for Allied to build a strong pipeline of products in the regenerative tissue area.

Allied Healthcare has 3 separate companies and businesses; Coridon, Allied Medical and Celxcel.

Coridon is a company focused on developing next generation DNA vaccines and was founded by Professor Ian Frazer, Australian of the Year 2006. Prof Frazer is well recognised for his groundbreaking research that led to Merck & Co.’s highly successful cervical cancer vaccine, Gardasil®.

Andrew Forrest, of Fortescue Minerals is one of the top 20 shareholders of Allied Healthcare Group.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

pSivida Corporation achieves commercial launch of eye disease treatment in Germany

Wed, 08 May 2013 11:10:00 +1000

pSivida Corporation’s (ASX: PVA, NASDAQ: PSDV) eye disease treatment, ILUVIEN®, is now commercially available in Germany, marking a major milestone for the company.

Importantly, ILUVIEN® is believed to be the first sustained release pharmaceutical in the European Union to treat chronic diabetic macular edema (DME).

pSivida will be entitled to 20% of the net profits from sales of ILUVIEN® by licensee Alimera Sciences in both Germany and the U.K., where the drug was previously launched.

The first patient has been treated with ILUVIEN® following the commercial launch in Germany.

In the European Union, ILUVIEN® has received marketing authorisation in Austria, France, Germany, Portugal, Spain and the U.K. and is awaiting authorisation in Italy.

Advancing U.S. approval

Last week pSivida revealed it had been notified by the U.S. Food and Drug Administration that its resubmission of a new drug application (NDA) for ILUVIEN® has been received and is considered a complete, class 2 response

Importantly, this means the company now has a new Prescription Drug User Fee Act (PDUFA) goal date of 17 October 2013.

The act authorises the FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of the PDUFA, user fees have played an important role in expediting the drug approval process.

If the FDA approves ILUVIEN®, pSivida would be entitled to an additional $25 million milestone payment from Alimera as well as 20% of net profits on any sales in the U.S.

New applications

pSivida plans to institute pivotal phase three clinical trials for the treatment of posterior uveitis, a chronic back-of-the-eye disease, with the same micro-insert as ILUVIEN® for DME.

An investigator-sponsored clinical trial is also ongoing for an injectable, bioerodible micro-insert to treat glaucoma and ocular hypertension.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

pSivida Corporation moves closer to U.S. approval for eye disease treatment

Thu, 02 May 2013 09:10:00 +1000

pSivida Corporation (ASX: PVA, NASDAQ: PSDV) has been notified by the U.S. Food and Drug Administration that its resubmission of a new drug application (NDA) for its eye disease treatment, ILUVIEN®, has been received and is considered a complete, class 2 response.

Importantly, this means the company now has a new Prescription Drug User Fee Act (PDUFA) goal date of 17 October 2013.

The act authorises the FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of the PDUFA, user fees have played an important role in expediting the drug approval process.

ILUVIEN® is used for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

In the resubmission of the NDA, pSivida’s licensee Alimera Sciences responded to the FDA’s complete response letter and provided additional analyses as well as new information to support that ILUVIEN® is safe and effective in the treatment of patients with chronic DME.

Using data from Alimera's two completed pivotal phase three clinical trials, the resubmission focused on the safety aspects of ILUVIEN® and the subgroup population of patients with chronic DME – the same subgroup for which marketing approval for the drug has been granted in six countries in the European Union.

At month 36, the treatment effect for the chronic DME subgroup was more than twice that seen for the overall population.

Given that the risks associated with the chronic DME subgroup are similar to the risks in the overall population, Alimera reported its belief that the benefit to risk for this subgroup is optimised with ILUVIEN® treatment.

If the FDA approves ILUVIEN®, pSivida would be entitled to an additional $25 million milestone payment from Alimera as well as 20% of net profits on any sales in the U.S.

pSivida is entitled to the same net profit share on sales of ILUVIEN® for DME by Alimera in the European Union, where Alimera has already launched in the UK and plans to launch in Germany in 2013.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Allied Healthcare Group on track for A$7M in sales for FY2013

Mon, 29 Apr 2013 11:20:00 +1000

Allied Healthcare Group (ASX: AHG) has generated over A$5.4 million in revenue so far this financial year, marking an 8% increase for the year to date, and is on track for more than $7 million in sales for the full 2013 financial year.

Importantly, this signals strong growth in revenue which will increase even further with the nearing commercial rollout of the company’s cardiovascular tissue patch, CardioCel®, in the U.S.

Allied expects full regulatory approval of CardioCel® in at least one jurisdiction in 2013.

During the March quarter, Allied filed its 510(K) marketing approval submission with the FDA for CardioCel®.

The U.S. is the largest global market for regenerative medicine and gaining approval gives Allied commercial entry.

Allied is now advancing its pre-commercial launch activities in preparation of approvals and launching CardioCel® in overseas markets.

The company’s cash balance was $3.77 million at the end of the March quarter following a successful A$4.6 million capital raising.

This will provide the company with sufficient capital to achieve its major milestones, including the initial approval and launch of CardioCel® and the initiation of the first clinical study for the DNA vaccine program.

CardioCel® continues to be used in patients to treat and repair congenital heart defects via the Authorised Prescriber Scheme in Australia.

Additionally, surgeons based in Melbourne and Brisbane have now been approved to use CardioCel® in patients.

This was supported by additional data from a phase two extension study which showed patients progressing well four years after receiving CardioCel®, with these patients showing no signs of calcification – a unique feature of the CardioCel® product.

Typically, calcium build-up at the site of repair can be seen within six months post-surgery with existing marketed products.

Allied anticipates additional early access approvals at key centres in Australia in the coming months.

During the March quarter, Allied also announced positive results from its regenerative tissue franchise in the areas of hernia repair, pelvic floor repair and stem cell seeding.

These results support the existing work with CardioCel® and show the potential for the company to build a strong pipeline of products in the regenerative tissue area.

Allied also further invested in its DNA vaccine programs, led by Professor Ian Frazer, as the lead herpes vaccine advances towards clinical trials expected to start in the first half of 2013.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Pulse Health Group substantial shareholder Wyllie Group ups stake

Fri, 26 Apr 2013 11:30:00 +1000

Pulse Health Group (ASX: PHG) substantial shareholder Wyllie Group has increased its shareholding in the company to 42.78%, from 40.72%.

Wyllie Group purchased a further 1.075 million shares for a total consideration of A$59,302, or around $0.05 per share, taking the total number of shares held to 194.9 million shares.

Earlier this week Pulse Health announced it had acquired the operating assets of the Westmead Rehabilitation Hospital – a move that will reduce the net debt of the company and establishes it as the clear and beneficial owner of the hospital.

Total consideration for the acquisition is $9.86 million, with settlement scheduled to occur on 31 May 2013.

Westmead Rehabilitation Hospital is a purpose built 60 bed private rehabilitation hospital located in Merrylands, Sydney, 3 kilometres south of Parramatta and within close proximity of Westmead Public Hospital and Westmead Private Hospital.

The fully equipped facility provides speech, occupational and physiotherapy along with psychological rehabilitation services to patients post-surgery, stroke and motor vehicle accidents.

Pulse Health is aiming to complete an expansion project at the hospital in fiscal 2014 to increase bed capacity.

As at 31 December 2012, Pulse Health had a total cash balance of $1.8 million plus an unused overdraft facility of $0.8 million.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Pulse Health Group completes share buyback

Tue, 23 Apr 2013 13:20:00 +1000

Pulse Health Group (ASX: PHG) has completed a share buyback of up to 20.4 million shares under its Long Term Incentive Scheme.

Under the scheme, each employee shareholder could choose to have their plan shares bought-back by the company.

Pulse Health has bought back 12.2 million Share A class shares at A$0.0516 each for a total consideration of $631,398.

All of the Share B and Share C class shares were not “in the money” and have been cancelled.

The $0.0516 buyback price represents the 45 day volume weighted average price of Pulse Health shares as was announced earlier this month.

The company now has around 455.5 million shares on issue.

Pulse Health has acquired the operating assets of the Westmead Rehabilitation Hospital – a move that will reduce the net debt of the company and establishes it as the clear and beneficial owner of the hospital.

Total consideration for the acquisition is $9.86 million, with settlement scheduled to occur on 31 May 2013.

Westmead Rehabilitation Hospital is a purpose built 60 bed private rehabilitation hospital located in Merrylands, Sydney, 3 kilometres south of Parramatta and within close proximity of Westmead Public Hospital and Westmead Private Hospital.

The fully equipped facility provides speech, occupational and physiotherapy along with psychological rehabilitation services to patients post-surgery, stroke and motor vehicle accidents.

Pulse Health is aiming to complete an expansion project at the hospital in fiscal 2014 to increase bed capacity.

As at 31 December 2012, Pulse Health had a total cash balance of $1.8 million plus an unused overdraft facility of $0.8 million.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Pulse Health acquires operating assets of Westmead Rehabilitation Hospital

Mon, 22 Apr 2013 11:20:00 +1000

The acquisition of the operating assets of Westmead Rehabilitation Hospital, a key hospital within the company’s portfolio, is a significant milestone for Pulse Health as it removes the restrictive nature of the security arrangements in place and better enables the company to influence operations at Westmead.

Allied Healthcare: More surgeons opt for early access to Cardiocel

Mon, 08 Apr 2013 09:30:00 +1000

Allied Healthcare (ASX:AHZ) has increased the number of Australian surgeons actively using or having received pre market authorisation from Therapeutic Goods Administration to use its cardiovascular patch CardioCel to five from one.

A number of additional surgeons are also engaged in the application process to use CardioCel via the Authorised Prescriber Scheme.

CardioCel is a cardiovascular patch used to repair paediatric heart deformities. The program has successfully completed a number of animal studies and a Phase II human clinical trial.

Dr Nelson Alphonso, director of paediatric cardiac surgery at the Mater Hospital in Brisbane joins fellow surgeon Dr Tom Karl to become the second surgeon at the hospital to receive TGA authorisation to use CardioCel from treating and repairing congenital heart defects under the APS.

Professor Christian Brizard of Melbourne University and his colleagues have gained early access to the use of the cardiovascular patch under a trial at a Melbourne based hospital.

The purpose of this new investigator-led clinical study is to expand the access to CardioCel in Australia. The early access clinical trial scheme will enroll up to 40 patients with congenital heart disease.

Allied anticipates CardioCel CE mark approval in mid-2013.

It had a cash balance of $1.98 million at the end of 31 December 2013 and raised $2.89 million this January via a share purchase plan at an issue price of $0.02 per share.

pSivida in pharma deal to test ophthalmic drug release technologies

Fri, 05 Apr 2013 13:40:00 +1100

pSivida (ASX:PVA, NASDAQ:PSDV) has entered into a funded technology evaluation agreement with a major global pharmaceutical company to evaluate its proprietary Durasert and Tethadur ophthalmic drug release technologies.

The Durasert technology system delivers specific quantities of drugs directly to a target site in the body at controlled rates for predetermined periods of time ranging from weeks to months.

Tethadur is pSivida’s proprietary technology for the delivery of proteins, peptides and antibodies.

pSivida has developed three of the four sustained release devices for retinal diseases that have been approved in either the US or Europe, the most recent being ILUVIEN partnered with Alimera and approved in multiple EU countries.

Independently, pSivida is developing an injectable, sustained release product to treat uveitis affecting the back of the eye (posterior uveitis) and an injectable, bioerodible product to treat glaucoma and ocular hypertension in collaboration with Pfizer.

It had a cash balance of $15.7 million as at 31 December 2012.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Pulse Health Group initiates share buyback

Tue, 02 Apr 2013 13:10:00 +1100

Pulse Health Group (ASX: PHG) plans to undertake a share buyback of up to 20.4 million shares under its Long Term Incentive Scheme.

Under the scheme, each employee shareholder can choose to have their plan shares bought-back by the company.

Pulse Health has determined that the share value will be calculated based on the volume weighted average price for the 45 trading days ending on, and including, Friday 5 April 2013.

With the acquisition of the Eden Rehabilitation Hospital, revenue from continuing operations grew to $24 million for the first half of the 2013 financial year, a $4.7 million or more than 24% increase over the same period in the previous financial year.

As at 31 December 2012, Pulse Health had a total cash balance of $1.8 million plus an unused overdraft facility of $0.8 million.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Allied Healthcare lodges U.S. premarket notification for heart tissue patch

Tue, 02 Apr 2013 11:25:00 +1100

Allied Healthcare Group has taken a major step towards commercialisation of its cardiovascular tissue patch in the U.S. with the lodging of its Premarket Notification 510(k) submission. The U.S. is the largest global market for regenerative medicine and gaining approval gives Allied commercial entry.

Greencross acquiring South Australian veterinary practice

Thu, 28 Mar 2013 15:50:00 +1100

Greencross (ASX: GXL) is continuing with its acquisition strategy, entering into an agreement to buy the Strathalbyn Veterinary Clinic in South Australia for A$900,000.

The clinic is expected to deliver annualised revenue and EBIT of $1.56 million and $257,000 respectively.

It is expected to be earnings per share accretive in the 2013 fiscal year.

This transaction is subject to deferred vendor payments of about 20% of the total consideration for a period of up to 24 months. The vendor has entered into an employment agreement for a minimum of 2 years.

Strathalbyn is a well established business that has been in operation in the area for about 40 years.

Greencross had last month raised $11.164 million via placement to sophisticated and institutional shareholders to advance its growth strategy and reduce its gearing levels.

Greencross is one of Australia's leading veterinary services company and has acquired and integrated 92 practices since it was started in 2003.

pSivida to resubmit ILUVIEN drug application to US regulators

Mon, 25 Mar 2013 09:40:00 +1100

pSivida's (ASX:PVA) will be resubmitting a New Drug Application for its ILUVIEN drug treatment for chronic diabetic macular edema (DME) to US regulators by end of this month.

The submission to US Food and Drug Administration will be made by Alimera Sciences, pSivida's licensee.

The resubmission will focus on the safety aspects of ILUVIEN and the population of patients with chronic DME considered insufficiently responsive to available therapies, using data from Alimera’s two previously completed pivotal Phase III clinical trials.

This is the same group for which marketing approval for ILUVIEN has been granted in various EU countries.

Approval in the U.S. would entitle pSivida to a $25 million milestone payment from Alimera and 20% of net profits, from U.S. sales of ILUVIEN by Alimera.

Alimera is also likely to ship ILUVIEN to German markets in the second quarter of this year, while shipments to the UK for treatment of privately insured patients will also start in the same quarter.

Meanwhile, the UK's Department of Health has agreed to a submission of a patient access scheme (PAS) to ILUVIEN for DME and is now under consideration by NICE for inclusion in rapid review facility.

Alimera said that under the review facility, NICE is expected to assess the impact of the PAS on ILUVIEN’s cost effectiveness and determine whether an update to the final guidance is warranted.

pSivida is a specialty pharmaceutical company that develops sustained release ophthalmic drug treatments.

pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert and BioSilicon.

The injectable, sustained release micro-insert ILUVIEN for the treatment of chronic Diabetic Macula Edema, licensed to Alimera has received marketing authorization in Austria, France, Germany, Portugal, the U.K. and Spain and is awaiting authorization in Italy.

Pulse Health Group director continues to buy shares on market

Tue, 12 Mar 2013 09:00:00 +1100

Pulse Health Group (ASX: PHG) director Andrew Gregory has further increased his stake in the company by another 533,544 shares on market.

Gregory bought the shares for a total consideration of A$29,874.2, providing an average entry price of $0.056 per share.

This takes his stake up to 36,929,281 shares held indirectly.

He had earlier this month acquired 1.6 million shares on-market.

Pulse Health continues to leverage the profitable private hospital sector, which is a strategy that is paying off.

With the acquisition of the Eden Rehabilitation Hospital, revenue from continuing operations grew to $24 million for the first half of the 2013 financial year, a $4.7 million or more than 24% increase over the same period in the previous financial year.

As at 31 December 2012, Pulse Health had a total cash balance of $1.8 million plus an unused overdraft facility of $0.8 million.

Allied Healthcare Group’s CardioCel® trial positive with no calcification after four years

Wed, 06 Mar 2013 10:40:00 +1100

Allied Healthcare Group (ASX: AHZ) has demonstrated that its CardioCel® implants continue to show no calcification four years after implantation in patients.

This is a significant milestone for the company as typically calcium build-up at the site of repair can be seen within six months post-surgery with existing marketed products.

European marketing approval for CardioCel® is expected by mid-2013.

CardioCel® is Allied’s lead regenerative tissue product for the repair and treatment of congenital heart defects (CHD).

Patients involved in an ongoing phase two extension study were assessed four years after their congenital heart defect was repaired using CardioCel®.

The assessment found no sign of calcium build-up at the site of repair, a result also seen when the same patients were reviewed at three years post-surgery.

Allied will continue to monitor these patients.

Lee Rodne, managing director, commented: “Four years without calcification when typically it is seen within six months post-surgery with existing marketed products is a significant result for us.”

“This provides additional positive data on CardioCel® and its potential to prevent repeated surgeries for patients with heart disease.”

Currently Allied is progressing CardioCel® for CE Mark approval in Europe as part of its global launch of the product.

The company also expects to file a 510(k) marketing approval submission with the U.S. Food and Drug Administration in the near future.

CardioCel® is currently being used in Australia at the Mater hospital in Brisbane under the Authorised Prescriber Scheme (APS) with other major hospitals expected to gain access through APS in the near future.

CHD market

Congenital heart disease is a leading cause of mortality in infants globally.

In Australia, six children are born with congenital heart disease every day and over 40,000 are born each year in the U.S.

In total there are 25 patients being followed in the extension study with seven beyond four years and another six over three years all without calcification.

Bob Atwill, chief executive officer of Allied’s Regenerative Medicine Division, said: “CardioCel® with its anti-calcification profile, regenerative properties and ease of handling has many advantages over existing tissue products used in surgery and offers surgeons, and patients, the real opportunity for reduced interventions in their long-term management.”

Well-funded

In late January Allied added a further A$2.9 million to its cash reserves with the completion of its share purchase plan.

Together with the $1.7 million placement completed in December 2012, Allied has raised a total of over $4.6 million, placing the company in a strong position for 2013.

The majority of the funds raised will be allocated to the preparation and market launch of CardioCel® and further building the company’s regenerative tissue franchise, which is expected to start generating revenue this year.

Indicating just how close Allied is to commercialisation of CardioCel®, the patch was used for the first time outside of clinical trials to surgically repair congenital heart defects in infants in mid-October 2012.

The market potential for CardioCel® is substantial. If the initial launch of the product is received well, revenue will increase significantly over the next 12 to 24 months.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Pulse Health Group director buys more shares on market

Tue, 05 Mar 2013 15:50:00 +1100

Pulse Health Group (ASX: PHG) director Andrew Gregory has increased his stake in the company with the purchase of a further 1.6 million shares on-market.

Gregory bought the shares for a total consideration of A$91,425, providing an average entry price of $0.057 per share.

Insider buying is considered by many as a "bullish" leading indicator.

Gregory now indirectly holds 36.4 million shares in Pulse Health.

Pulse Health continues to leverage the profitable private hospital sector, which is a strategy that is paying off.

With the acquisition of the Eden Rehabilitation Hospital, revenue from continuing operations grew to $24 million for the first half of the 2013 financial year, a $4.7 million or more than 24% increase over the same period in the previous financial year.

Excluding the Eden acquisition costs of $0.3 million, net profit after tax was $1 million, a 69.6% increase over the previous corresponding period.

As at 31 December 2012, Pulse Health had a total cash balance of $1.8 million plus an unused overdraft facility of $0.8 million.

The company continues to trade in advance of prior comparatives and is well placed to generate increased returns.

Pulse Health is progressing its brownfield expansion plans, which is expected to add bed capacity during 2013.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Pulse Health Group substantial shareholder Wyllie Group increases stake

Mon, 04 Mar 2013 10:10:00 +1100

Pulse Health Group (ASX: PHG) substantial shareholder Wyllie Group has increased its shareholding in the company to 40.72%.

Wyllie Group purchased a further 2.4 million shares for a total consideration of A$117,488, or around $0.05 per share taking the total number of shares held to 193.8 shares.

Pulse Health Group continues to leverage the profitable private hospital sector, which is a strategy that is paying off.

With the acquisition of the Eden Rehabilitation Hospital, revenue from continuing operations grew to $24 million for the first half of the 2013 financial year, a $4.7 million or more than 24% increase over the same period in the previous financial year.

Net profit before tax was $0.8 million, which is a $0.3 million improvement on the first half of the 2012 financial year.

Excluding the Eden acquisition costs of $0.3 million, the net profit after tax was $1 million, a 69.6% increase over the previous corresponding period.

EBITDA came in at more than 27%, or $0.6 million, higher at $2.8 million.

Pulse Health decreased its net debt position by $0.4 million to $23.5 million in the first half of the 2013 financial year.

Strong outlook

The company continues to trade in advance of prior comparatives and is well placed to generate increased returns.

Pulse Health is progressing its brownfield expansion plans, which is expected to add bed capacity during 2013.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Allied Healthcare Group rated ‘outperform’ by RBS Morgans, $0.061 price target

Tue, 26 Feb 2013 13:55:00 +1100

RBS Morgans has placed a $0.061 share price target and an “outperform” rating on Allied Healthcare Group, with the key catalyst being marketing approval of CardioCel® in Europe.

Greencross raises $11.16M via placement; adds Sydney vet hospital to its stable

Mon, 18 Feb 2013 12:50:00 +1100

Greencross (ASX:GXL) has raised $11.164 million via placement to sophisticated and institutional shareholders, with the company keeping a keen eye on potential acquisitions.

The 3.28 million shares were placed at $3.40 a piece, representing a discount of 8% to a 30 day volume weighted average prior to close of trading on 12 February.

The placement, which was oversubscribed saw the support of existing shareholders as well as new participation by many domestic and international institutional investors.

The company remains steadfast in its target to acquire 1 to 2 new clinics per month on multiples of between 3 to 4.5 times EBIT, which will be funded through a mix of debt, free cash and vendor deferred payments.

Cash from this placement will also help with its growth strategy while also reducing its gearingg levels.

Separately, Greencross has entered into an agreement to acquire a very large veterinary hospital in Sydney for a cash consideration of $5 million.

The acquisition is likely to deliver annualised revenue and EBIT of $5.4 million and $1.1 million respectively and will be earnings per share accretive this year.

Greencross is one of Australia's leading veterinary services company and has acquired and integrated 89 practices since it was started in 2003.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Greencross to increase cash reserves

Thu, 14 Feb 2013 10:30:00 +1100

Vet-acquisition play Greencross (ASX: GXL) is initiating a capital raising, with the ASX granting the company a trading halt this morning, with its shares placed in pre-open.

Greencross has been a strong performer on the ASX over the past twelve months, with the current $3.80 share price just off recent highs of $4.10, but well up on the $1.40 range where the company was trading a year earlier.

The halt will last until the earlier of an announcement being made to the market, or the opening of trade on Monday 18th February 2013.

Allied Healthcare Group closer to CE Mark approval for CardioCel®

Wed, 13 Feb 2013 10:20:00 +1100

Allied Healthcare Group (ASX: AHZ) is closer to securing European CE Mark approval for its CardioCel® product having now received ISO 13485 certification, a key part of the CE approval process.

European marketing approval for CardioCel® is expected by mid-2013.

CardioCel® is Allied’s lead regenerative tissue product for the repair and treatment of congenital heart defects (CHD).

The company has now successfully completed stage one and two audits resulting in the receipt of the ISO certification.

Lee Rodne, managing director, commented: “Obtaining ISO 13485 is a critical step along the path to obtaining a CE Mark, which opens up the European Union market as well as many other markets around the world to grow significant revenue from our lead regenerative tissue product starting in 2013.

“This will also assist in Allied obtaining its Health Canada Medical Device Licence for CardioCel®.”

Certification against ISO 13485 indicates that Allied has successfully implemented a Quality Management System that conforms to the International Organization for Standardisation (ISO) standards for medical devices.

ISO 13485 is an internationally recognised standard defining requirements for the design, development and manufacturing of safe medical devices.

Allied has also recently successfully undergone a Quality Management System audit by the Therapeutic Goods Administration as part of the Conformity Assessment Review of CardioCel®.

Bob Atwill, chief executive officer of Allied’s Regenerative Medicine Division, said: “Obtaining ISO 13485 for our Quality Management System and having undergone a TGA audit are significant achievements as we progress through the CardioCel® regulatory processes.”

CardioCel® has the potential to have a major impact on many global markets for repairing and treating cardiovascular defects.

It shows clear advantages over existing products and addresses a number of major issues in this space faced by surgeons, mainly the prevention of calcification, its regenerative tissue benefits and ease of use.

Allied is also evaluating other applications for its ADAPT® tissue engineering platform technology, such as its use in pelvic floor reconstructions, hernia repairs, orthopaedics and as a biological scaffold to grow and deliver stem cells.

Capital raising

Allied recently added a further A$2.9 million to its cash reserves with the completion of its share purchase plan.

Together with the $1.7 million placement completed in December 2012, Allied has raised a total of over $4.6 million, placing the company in a strong position for 2013.

The majority of the funds raised will be allocated to the preparation and market launch of CardioCel® and further building the company’s regenerative tissue franchise, which is expected to start generating revenue this year.

Indicating just how close Allied is to commercialisation of CardioCel®, the patch was used for the first time outside of clinical trials to surgically repair congenital heart defects in infants in mid-October 2012.

The market potential for CardioCel® is substantial. If the initial launch of the product is received well, revenue will increase significantly over the next 12 to 24 months.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Greencross grows interest in Pet Accident and Emergency Pty Ltd

Tue, 05 Feb 2013 17:55:00 +1100

Greencross (ASX: GXL) has increased its interest in Pet Accident and Emergency Pty Ltd to 90% following the acquisition of an additional 8% stake for A$179,720.

The acquisition is expected to be earnings per share accretive in the 2013 fiscal year.

Consideration will be part settled by the issue of 49,928 Greencross shares to the vendors.

The issue price of $2.90 per share is consistent with the share price offered to the vendors of the recent Greencross Vets Toowoomba Pty Ltd and Greencross Vets South Coast Pty Ltd.

Greencross said it expects this to be the last transaction in relation to the conversion of subsidiary shareholdings into Greencross scrip at $2.90 per share.

Validating acquisition strategy

Greencross expects to record underlying earnings of between $7.8 and $8.2 million for the half year ended 31 December 2012, reflecting the success of its vet acquisition strategy.

This is up 32.1% to 38.8% over the earnings before interest, taxes, depreciation and amortisation of $5.9 million that it made in the half year ended 31 December 2011.

Revenues are expected to be up between 31.8% and 34.4% to between $52 and $53 million from the $39.4 million in the previous corresponding period.

The company expects to have cash on hand of $6.8 million at the end of the half year while the unutilised acquisition funding facility with the Commonwealth Bank stands at $9.7 million.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Allied Healthcare Group looks for further revenue growth in 2013

Wed, 30 Jan 2013 10:20:00 +1100

Allied Healthcare Group (ASX:AHZ) has kicked off 2013 by adding $2.9 million to its cash balance of $1.99 million at the end of the December quarter from a share purchase plan.

For the current financial year, Allied Healthcare has also earned $3.64 million in revenues, up 10% for the year to date.

The company is forecasting continued growth in revenues.

The current cash balance will see the company with sufficient capital to achieve its major milestones.

This includes the initial approval and launch of CardioCel® and the initiation of the first clinical study for the DNA vaccine program.

The company's lead regenerative tissue product CardioCel® was successfully used in first patients during the quarter to treat and repair congenital heart defects.

This was after the company received early approval via the Authorised Prescriber Scheme in Australia in the previous quarter.

Additional early access approvals are expected at key centres in Australia in the coming months and full regulatory approval of CardioCel® in at least one jurisdiction in 2013.

A successful heart valve reconstruction study was completed in the quarter utilizing CardioCel® that demonstrated strong tissue regeneration in heart valve tissue as well as having the mechanical properties and characteristics required to be suitable material to reconstruct and repair heart valves.

The company is now advancing its pre-commercial launch activities in preparation of approvals and launching CardioCel in overseas markets.

Another milestone for the company are its DNA vaccine programs led by Professor Ian Frazer, which is focused on the lead Herpes vaccine as it advances towards clinical trials expected to start in the first half of 2013.

Greencross validates acquisition strategy with earnings, revenue growth expected

Fri, 25 Jan 2013 16:20:00 +1100

Greencross (ASX: GXL) expects to record underlying earnings of between $7.8 and $8.2 million for the half year ended 31 December 2012, reflecting the success of its vet acquisition strategy.

This is up 32.1% to 38.8% over the earnings before interest, taxes, depreciation and amortisation of $5.9 million that it made in the half year ended 31 December 2011.

Revenues are expected to be up between 31.8% and 34.4% to between $52 and $53 million from the $39.4 million in the previous corresponding period.

Underlying net profit after tax is also expected to be up by up to 37% to $3.6 million, though the company noted that it may report a net profit of between $1.2 and $1.5 million due to its auditor disputing the accounting treatment of eight deferred purchase payments.

Greencross noted the one-off accounting adjustment did not affect underlying earnings or its ability to distribute 50% of underlying earnings in dividends to shareholders.

It also confirmed there is no impact on its funding arrangements with its financiers, Commonwealth Bank, and that it would continue to make acquisitions.

The company expects to have cash on hand of $6.8 million at the end of the half year while the unutilised acquisition funding facility with CBA stands at $9.7 million.

Allied Healthcare Group completes A$4.6M raising to launch CardioCel®

Wed, 23 Jan 2013 10:30:00 +1100

Allied Healthcare Group is in a strong financial position for 2013 having raised A$4.6M in a recent capital raising. The company is well funded to focus getting its first regenerative product, CardioCel®, approved and launched.

pSivida Corporation breaks into Spanish eye disease treatment market

Fri, 18 Jan 2013 11:50:00 +1100

pSivida Corporation (NASDAQ: PSDV) has reached the milestone granting of marketing authorisation for its eye disease treatment, ILUVIEN®, by the Spanish Agency of Drugs and Medical Devices.

Marketing authorisation has now been received for six of the seven European Union countries pSivida is targeting. Approval has already been granted in Austria, the United Kingdom, Portugal, France and Germany.

ILUVIEN® is used for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

The product is expected to be the first sustained release pharmaceutical in the European Union to treat DME.

The market potential for the product in Spain is substantial, with more than 3 million people living with diabetes and around 160,000 suffering from vision loss associated with DME.

Licensee Alimera Sciences continues to work closely with regulatory authorities in Italy to secure marketing authorisation in the country.

The initial commercial launch of ILUVIEN® in Germany is slated for the March quarter 2013.

The marketing authorisations follow the completion of the Decentralized Regulatory Procedure in the European Union, in which the Medicines and Healthcare products Regulatory Agency in the United Kingdom, serving as the Reference Member State, delivered a positive outcome for ILUVIEN® along with six Concerned Member States.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

Allied Healthcare Group unlocks further potential of regenerative tissue technology

Thu, 10 Jan 2013 10:30:00 +1100

Allied Healthcare Group (ASX: AHZ) is achieving further success in the development of its ADAPT®-treated tissue as a bioprosthetic substitute for abdominal hernia repairs as well as pelvic floor reconstructions.

A comparative study carried out on an experimental model showed the ADAPT® tissue was superior or equal to the comparative synthetic implant.

No macroscopic evidence of calcification or visible immunological responses was found in the explanted ADAPT®-treated tissue in both the hernia and pelvic floor reconstructions at the end of the study period.

Significantly, these positive results expand the potential for ADAPT®-treated tissue to be used in other applications, opening up potential new revenue streams.

Lee Rodne, managing director, commented: “These results are significant in building further revenue in areas outside of CardioCel® for cardiovascular applications.

“With combined markets of over $750 million we are excited about the future prospects of building significant revenue for our group and bringing to market innovative regenerative tissue products developed from our Regenerative Medicine Division.”

Assessment of the physical properties of the explanted ADAPT®-treated tissues after six months demonstrated a better outcome than the control.

The ADAPT®-treated tissue remained stable and intact without any significant deformation of the original shape (configuration) and size (dimensions) compared to synthetic meshes which tended to contract and shrink.

For hernia repair, the study demonstrated the outstanding performance of ADAPT®-treated tissue as a substitute for abdominal hernia repairs compared to alternative synthetic controls which tend to fail due to tissue erosion, implant exposure and infections after implantation.

For pelvic floor repairs, the macroscopic results with the ADAPT®-treated tissue in the pelvic floor reconstructions demonstrated comparable results in the vaginal area with the synthetic controls.

These results compared favourably in terms of maintaining significantly low rates of implant exposure, erosion of surrounding tissue and infection when compared to synthetic materials currently in the market place.

The study was undertaken in collaboration with world known gynecologist, Professor Jan Deprest, from The University of Leuven in Belgium.

Firming regenerative performance

Allied recently announced that its lead regenerative tissue product CardioCel®, made using the ADAPT® process, showed significant tissue regeneration post implantation in cardiovascular repair.

The independent validation of these latest results confirms the regenerative performance of the ADAPT® treated tissue and provides an opportunity to confirm the efficiency of the ADAPT®-treated tissue in surgical repairs and reconstructions.

These results provide additional evidence that ADAPT® prepared tissue shows no signs of calcification and supports tissue regeneration, clear advantages over existing tissue products available.

Revenue growth

Bob Atwill, chief executive officer of Allied’s Regenerative Medicine Division, said: “These externally validated results for Hernia repair and Pelvic Floor reconstruction, along with the recent regenerative results for CardioCel® indicate a very positive path to significant revenue growth for Allied Healthcare Group.”

“We have a great data package and will be pushing forward with our plans for a hernia product to follow on from CardioCel® which is already being used in Australia.”

Importantly, these latest results demonstrate Allied has the potential to build significant surgical tissue franchises in hernia repair, pelvic floor reconstructions, as well as other areas such as orthopaedics and as a biological scaffold to grow and deliver stem cells.

The company is looking to present the full data at an international scientific meeting and publish the study results in a peer reviewed publication in the near future.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

HealthLinx Limited appoints new non-executive director

Wed, 02 Jan 2013 11:00:00 +1100

HealthLinx Limited (ASX: HTX) has appointed Malcolm Lucas-Smith as a non-executive director of the company.

This follows the resignation of John Evans as a non-executive director due to increasing work commitments related to other entities outside of HealthLinx.

Evans joined HealthLinx’s board in March 2008 and has made significant contributions to the progress of the company during his tenure.

Lucas-Smith has been the Company Secretary since 2003 and will continue in that role.

Allied Healthcare Group: Coridon’s Ian Frazer receives grant for HPV vaccine development

Thu, 20 Dec 2012 10:58:00 +1100

A $200,000 grant from Australia’s National Health and Medical Research Council will assist in advancing the development of Professor Ian Frazer’s novel HPV vaccine, which will be used not only as a prevention of the disease, but also as a treatment. The commercial market for such a vaccine, if successful, is assessed at over $1.3B per annum.

Allied Healthcare Group completes oversubscribed A$1.7M capital raising

Mon, 17 Dec 2012 10:31:00 +1100

Allied is on the cusp of launching its CardioCel® heart patch and the A$1.7M in funds raised will support the product’s commercialisation. Approval of CardioCel® will represent a major inflection point for the company as it is expected to result in a significant increase in global revenue.