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There’s a strong possibility that you have experienced lower back pain or heard of injuries in which spinal discs are damaged either because of age related degeneration, playing sports, accidents, or other physical and genetic conditions. The spinal disc is the cushion between the bones or vertebra in the spine that allows for motion and stability. Currently, there is no treatment to regenerate the spinal disc, which often relates to intense pain causing patients to turn to major surgical procedures, that can lead to complications or opioid use, which can lead to addiction.
Now, imagine a future where it’s possible to completely heal such injuries and regenerate not only the spinal discs, but also other body tissue and cartilage, restoring them to their original state. The medical implications would be far reaching. This future isn't as far off as one would think, thanks to trailblazers such as HippoFi, Inc. (OTC:ORHB) through its wholly owned subsidiary PUR Biologics.
HippoFi’s main goal is to give back to patients the quality of life they had prior to when injuries or the aging process took their toll and eliminate the risks of surgery and dependency on painkillers.
PUR’s complete line of biologic products currently includes advanced allografts and demineralized extracellular matrices (d-ECM), innovative synthetic bone-forming solutions, and cellular-derived tissues. In addition to this, the company has several patented and next-generation regenerative stem cell and growth factor driven therapeutics for treating osteoarthritis and cartilage regeneration.
PUR’s product and technology portfolio are applicable to multiple large markets which conservatively could be worth about $48 billion providing the opportunity for continued growth, and increased shareholder value.
Investors should be most excited for the company’s recent addition to the executive team. There is no one better placed to help HippoFi capitalize on the huge opportunity in regenerative therapeutics than the world’s foremost authority and pioneer of regenerative medicine, Gail Naughton, MBA, Ph.D.
Despite their massive potential, very few cell-based products have been approved by regulatory authorities. This is understandable considering these are complex products which are difficult to manufacture. Dr. Naughton has an extensive track-record in this space, with more cell-based products approved by the FDA than nearly anyone else in the world, making her an extremely valuable addition to the team.
A pioneer in cell-based therapeutics
Dr. Naughton will be HippoFi’s "Head of Regenerative Therapeutics and Commercialization" and has been a driving force in regenerative medicine for over 35 years with a proven track record in monetizing significant cell-based therapeutics and bioengineered tissue technologies in addition to holding more than 140 patents.
The first company that Dr. Naughton started and went public with was Advanced Tissue Sciences, which then was acquired by Organogenesis (NASDAQ:ORGO). Advanced Tissue Sciences was started in 1988 and received three of the world’s first regulatory approvals for cell-based products, including approval for Transcyte, a “skin substitute” originally termed Dermagraft, a product placed on diabetic ulcers and used for a soft tissue filler and as a cover to help the tissue heal.
The company worked closely with healthcare giant Smith & Nephew (NYSE:SNN), a leader in advanced wound care and orthopedics which very early on recognized the potential of these cell-based products. The joint venture, focused on wound care and orthopedics, not only reaffirmed the potential for these novel cell-based products but also highlighted why Dr. Naughton was indeed the foremost authority on regenerative therapies. At the same time, Advanced Tissue Sciences licensed its first skincare product to a company called SkinMedica which was eventually acquired by Allergan. Though AbbVie (NYSE:ABBV) bought out Allergan, that skincare product is still being sold.
Dr. Naughton went on to start a second company called Histogen which went public as well. The company focuses on growing cells under embryonic conditions of very low oxygen and low gravity in order to revert the cells back to a stem-cell like condition. It then uses the byproducts of those cells in a very controlled manufacturing process to produce growth factors and extra-cellular matrix for a variety of reasons, including the regeneration of spinal discs which has demonstrated success in animal trials and the regeneration of the surface cartilage in joints which has gone to clinical trials.
Dr. Naughton understands the pathways and potential pitfalls of bringing cellular and cellular derived technologies through the manufacturing process, animal trials, and clinical trials as well as working closely with the FDA which will be instrumental for HippoFi going forward. Furthermore, Dr. Naughton oversaw the design and development of the world’s first up-scaled manufacturing facility for tissue engineered products reaffirming her position as the world’s leading mind in manufactured cell-based products. Although currently focused on spine, the company has the ability to develop other orthopedic and bone care products as well as improve current products.
Expediting the development of regenerative therapies
HippoFi, Inc. (OTC:ORHB) has already achieved significant success in the regenerative therapies space, succeeding where others have failed. With the new commitment to work with Dr. Naughton, their combined efforts and revolutionary vision should be able to expedite the development of fully functioning biologics solutions in orthopedics that not only regenerate but restore function.
One of Dr. Naughton and Hippofi’s first moves will be to continue the work she has been doing which has already shown success in animal studies. The exceptional results from these studies have shown that these novel biologic solutions could regenerate the spinal discs to the way they were before they had degenerated or were damaged, which ties in well with HippoFi’s current product portfolio and innovation focus. With such encouraging results, this means that the treatments would essentially be able to ‘turn the clock backwards’ and restore a patient’s tissues, functionality, and pain levels to the point they were before aging, disease, or injury.
Dr. Naughton recently had success getting into clinical trials for human cartilage regeneration, another key area of focus for HippoFi. This is different than repairing because when tissue repairs it usually leaves a scar. HippoFi’s goal is to be able to have the normal tissue / cartilage / disc to regenerate back to where it was originally, without scarring.
Right now, HippoFi is focused on the spine, mostly targeting bone growth products to help heal following spinal fusion procedures. And while that has been a great advancement for the patients, the company is concentrating on spine first because that’s where it has extensive experience and worldwide sales channels to drive today’s revenues. While Dr. Naughton also has significant experience in spine; their shared vision and experience will expand their target to other areas as they make more successes.
Takeaway
Although cell-based and cell-derived products and regenerative therapies have been around since the mid-80s, there are only a handful of products that have been approved by the FDA which has recently opened up new pathways to approval, seeing the importance of these technologies related to the future of patient care. With the addition or Dr. Naughton, and the company’s issued patent portfolio, HippoFi, Inc. (OTC:ORHB) is well positioned to change this and lead the future of regenerative medicine. With her extensive background in regenerative medicine and regulatory pathways combined with HippoFi’s business, sales, and clinical expertise they have clearly created a vision and strategy to expedite these innovative products to the patients that need them most - starting with spinal discs and osteoarthritis, and then moving forward with the regeneration of cartilage in knees and other joints..
For now, it seems that is the perfect time for investors to keep a watchful eye on HippoFi, and the addition of Dr. Naughton will be a major catalyst in helping the company meet their goals and address the significant and unmet needs in the $200 billion osteoarthritis, pain, and cartilage & spinal disc regeneration markets. Although the company currently has a market cap of just about $25 million, it may not remain at that valuation for too long once it starts gaining mainstream attention.
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