Orthocell (ASX:OCC) has taken a significant step forward in its efforts to introduce its SmrtGraft product to the Australian market.
The company has submitted an application to the Therapeutic Goods Administration (TGA) seeking approval to commence sales of SmrtGraft, which is designed for tendon repair and regeneration applications.
This move comes on the heels of positive results from Orthocell’s tendon regeneration study, which demonstrated that SmrtGraft can reduce the rate of treatment failure and the need for revision surgeries.
Every participant in the study experienced successful tendon repair, accompanied by notable enhancements in pain relief, function, and overall quality of life.
Importantly, none of the individuals required additional surgery due to a re-tear of the rotator cuff tendon. This outcome is particularly significant given that re-tear revision surgeries reportedly occur in up to 57% of cases.
If approved, SmrtGraft will join Orthocell’s portfolio of revenue-generating products, which already includes Striate+ for dental bone regeneration and Remplir for peripheral nerve repair.
The market potential for SmrtGraft is significant, with an estimated worth of more than US$1.2 billion annually, says Orthocell.
In Australia, the United States, and the European Union alone, there are over 800,000 surgical repairs of rotator cuff tendons completed each year.
“Australia is an important stepping stone to other very large and attractive international target markets, including the USA,” said Orthocell’s CEO, Paul Anderson.
“This is another significant milestone in our product expansion strategy. Once approved, it will be Orthocell’s third revenue generating medical device available in Australia.”
SmrtGraft is a tool used to protect and support surgically repaired tendons, helping them heal better. Studies have shown that without such support, there’s a high chance of the repaired tendons tearing again, often at a rate of up to 57%.
But with SmrtGraft, there’s hope for reducing this risk. Although the study mainly looked at rotator cuff tendon repairs, SmrtGraft could potentially be used for other tendon repairs in various parts of the body, like the knee, hip, ankle, elbow, wrist, and hands.
FDA grants Orphan Drug Designation to Recce’s RC220 Bisantrene
Meanwhile, Race Oncology (ASX:RAC) said that the US FDA has extended Orphan Drug Designation (ODD) to Race’s proprietary formulation of bisantrene, RC220.
This designation, originally granted to Update Pharma Inc in 2014 for the RC110 formulation, was transferred to Race in 2017 and has been maintained through annual reporting to the FDA on clinical and non-clinical activities involving bisantrene.
The Orphan Drug Designation program was established by the US FDA under The Orphan Drug Act of 1983 to encourage the development of drugs, biologics, devices, or medical foods for rare diseases or conditions affecting fewer than 200,000 people within the US.
This legislation has resulted in the development and approval of 1240 new treatments and drugs.
Being granted Orphan Drug Designation offers various benefits to sponsors of new treatments for orphan diseases.
These include seven-year US marketing exclusivity, a 25% federal tax credit for clinical research expenses incurred in the USA, waiver of fees under the Prescription Drug User Fee Act (PDUFA).
Additionally, it makes recipients eligible to receive research grants from the Office of Orphan Products Development (OOPD) and allows access to further regulatory assistance and guidance from the FDA.
“Race continues to advance bisantrene as a novel treatment for AML (Acute myeloid leukemia), however being able to leverage the additional regulatory and guidance support from the FDA that ODD provides is very welcome,” said Race’s Dr Daniel Tillett.
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