Proactive Investors - Run By Investors For Investors

Cyclopharm eyes faster market entry for Technegas following positive US FDA meeting

Technegas is inhaled by patients and allows the diagnosis of multiple respiratory diseases via imaging and analytical software
lungs
Commercial sales expected to commence in the US during 2019

Cyclopharm Limited (ASX:CYC) has opened up an alternative pathway for the approval of its Technegas generator following a meeting with the United States Food and Drug Administration (US FDA).

The Technegas generator produces a gas which is inhaled by patients before taking scans, to assist in the detection of respiratory diseases.

The newly proposed pathway is likely to allow for a faster market entry and reduced risk profile.

As a result, Cyclopharm is likely to be in a position to submit its New Drug Application for Technegas during the first half of 2019.

READ: Cyclopharm achieves another milestone for its Technegas technology in the US

Cyclopharm managing director James McBrayer said: “Being allowed to submit a New Drug Application protocol for Technegas via a 505 (b)2 pathway significantly de-risks the FDA approval process, gives confidence to our timeline target to start sales of Technegas in the US in 2019 and is likely to reduce the anticipated overall costs (USD $7.5 million) of gaining approval USFDA substantially.

“We will redeploy any savings we make from adopting this alternative approval pathway to building the distribution, sales and marketing capabilities needed to initiate US sales in 2019.”

Aiming for 50% share of the US market

The US accounts for around half of the total addressable global market for Technegas.

The existing market for nuclear medicine ventilation imaging in the US is estimated to be about US$90 million annually, representing 600,000 individual procedures

Based on its Canadian experience, Cyclopharm believes that Technegas can achieve a 50% share of the US market over 2 to 3 years, post-market entry, with an 80% share representing about 480,000 procedures per annum achievable over a 7-year period.

View full CYC profile View Profile

Cyclopharm Ltd Timeline

Related Articles

cancer
May 14 2018
Physiomics' share price surged on a €500,000 contract for its virtual tumour software with Merck KgaA.
Nemaura Medical Inc CEO Dr Faz Chowdhury
November 06 2018
The medtech company is eying explosive growth with sugarBEAT, on the cusp of launching in the UK, followed by the rest of Europe in 2018
Proton Therapy sign
October 10 2018
The broker says the cancer treatment developer could potentially take the entire share of the growth market from ageing cyclotron companies

© Proactive Investors 2018

Proactive Investors Australia PTY LTD ACN:132787654 ABN:19132787654.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use