NovaBay Pharmaceuticals, Inc. and BioStem Technologies, Inc. have entered into an agreement for NovaBay to receive the commercial rights to BioStem’s Amniotic Tissue Allograft.
Refresh me on BioStem.
BioStem Technologies is a Florida-based regenerative biotechnology company with a focus on producing perinatal tissue-based allografts that use the body’s natural biology to potentially repair or reverse damage from a wide spectrum of degenerative diseases.
And amniotic allografts?
Amniotic allografts are human amniotic fluid and/or amniotic membrane tissues that have been minimally manipulated into either a liquid or patch.
Historically-speaking, these allografts have been used in regenerative medicine, where they are placed on or around a wound to “cover,” protect, and nourish the tissue.
Now this Amniotic Tissue Allograft.
The prescription-only product is an ultra-thin, ultra-light structural tissue allograft composed of the placental membrane’s amnion layer, according to BioStem CEO Jason Matuszewski.
The allograft is intended to provide coverage of the cornea and conjunctiva during the healing process—allowing for rehabilitation of the ocular surface.
To note, it is also currently the only ophthalmic allograft manufactured using BioStem’s BioREtain—a patented, six-step manufacturing process designed to preserve the biologic quality of the tissue critical to the wound healing process.
And Avenova is … ?
Avenova is formulated with NovaBay’s patented and FDA-cleared formula of 0.01% pure hypochlorous acid (HClO), designed and clinically tested for relieving chronic eye conditions: dry eye, blepharitis, meibomian gland dysfunction (MGD), contact lens intolerance, and inflammation.
NovaBay’s Avenova over-the counter (OTC) products include:
- Avenova Eye Health Support Oral Supplement with MaquiBright
- Avenova Eye Compress
- Avenova Lubricant Eye Drops
- iCheck by Avenova
These products can be used with all other prescriptions and OTC products, according to NovaBay.
And the tie-in with this allograft?
The company plans to commercialize the product as Avenova Allograft in order to leverage its Avenova eyecare brand, with the intent to encourage use within the Avenova portfolio.
Will this be covered by Medicare?
Per a company news release, medically-necessary procedures with the Avenova Allograft will be reimbursed through Medicare.
When will this launch?
NovaBay will launch the product in the coming weeks, according to NovaBay CEO and General Council Justin Hall.
The goal, Hall stated, is to“[make] this valuable solution available for eyecare professionals who specialize in treating dry eye.”
And the bigger picture?
The newly-branded allograft will join a growing global ophthalmology amniotic membrane market, estimated to be $403.6 million in 2022 and expected to grow 9.8% per year in the next 8 years, per market reports.