StemCell Therapy

Aziyo Biologics, Inc. is slated to price its IPO on Wednesday, October 7th.

From the prospectus:

"We are a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improving outcomes in patients undergoing surgery, concentrating on patients receiving implantable medical devices. From our proprietary tissue processing platforms, we have developed a portfolio of advanced regenerative medical products that are designed to be very similar to natural biological material. Our proprietary products, which we refer to as our Core Products, are designed to address the implantable electronic device/cardiovascular, orthopedic/spinal repair and soft tissue reconstruction markets, which represented a combined $3 billion market opportunity in the United States in 2019. To expand our commercial reach, we have commercial relationships with major medical device companies, such as Boston Scientific and Medtronic, to promote and sell some of our Core Products. We believe our focus on our unique regenerative medicine platforms and our Core Products will ultimately maximize our probability of continued clinical and commercial success and will create a long-term competitive advantage for us."

"We estimate that more than two million patients were either implanted with medical devices, such as pacemakers, defibrillators, neuro-stimulators, spinal fusion and trauma fracture hardware or tissue expanders for breast reconstruction, in the United States in 2019. This number is driven by advances in medical device technologies and an aging population with a growing incidence of comorbidities, including diabetes, obesity and cardiovascular and peripheral vascular diseases. These comorbidities can exacerbate various immune responses and other complications that can be triggered by a device implant."

"Our Core Products are targeted to address unmet clinical needs with the goal of promoting healthy tissue formation and avoiding complications associated with medical device implants, such as scar-tissue formation, capsular contraction, erosion, migration, non-union of implants and implant rejection. We believe that we have developed the only biological envelope, which is covered by a number of patents, that forms a natural, systemically vascularized pocket for holding implanted electronic devices. We have a proprietary processing technology for manufacturing bone regenerative products for use in orthopedic/spinal repair that preserves a cells ability to regenerate bone and decelerates cell apoptosis, or programmed cell death. We have a patented cell removal technology that produces undamaged extracellular matrices for use in soft tissue reconstruction. In pre-clinical and clinical studies, our products have supported and, in some cases, accelerated tissue healing, and thereby improved patient outcomes."

"COMPETITION: Our Core Products compete primarily with implantable electronic device envelopes and other cardiovascular repair products, other orthobiologics and human-derived acellular dermis products. The CanGaroo envelope competes with the synthetic envelope TYRX from Medtronic (NYSE:MDT). ProxiCor, Tyke and VasCure compete with bovine pericardium produced by numerous companies, including Gores Goretex and Terumos (OTCPK:TRUMF) Vascutek. FiberCel, ViBone and OsteGro V compete with other viable bone matrices, such as Smith & Nephews (NYSE:SNN)Bio4, MTFs Trinity ELITE, NuVasives (NASDAQ:NUVA) OsteoCel, Vivex Biologics VIA Graft and LifeNet Healths ViviGen. SimpliDerm competes primarily against human-derived acellular dermis matrix meshes, including AbbVies (NYSE:ABBV)AlloDerm, Surgalign Holdings (NASDAQ:SRGA)Cortiva, Strykers (NYSE:SYK) DermACELL andEthicons FlexHD. SimpliDerm also competes against animal-derived biological mesh products, such as AbbVies Strattice and Integras (NASDAQ:IART) SurgiMend, as well as various synthetic mesh products."

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Aziyo Biologics to price IPO on Oct. 7th; competitors include ABBV, MDT, SRGA and SYK - Seeking Alpha

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