In his role at SkelRegen, Wozney will set experimental design and direction; lead collaboration with development partners; build alternative R&D pathways; and optimize project quality, cost and time variables.

Wozney is an internationally recognized expert in the key-signaling molecules involved in the growth and maintenance of bone and soft tissues called bone morphogenetic proteins (BMPs), and musculoskeletal biology. He joins the SkelRegen team from the Genetics Institute (acquired by Wyeth and subsequently Pfizer), where he conducted research leading to the identification of BMP. He then played a key role in the commercialization of a genetically engineered protein (rhBMP-2) and the development of a local delivery system as an innovative bone-inductive therapeutic, which has found widespread use in orthopaedics.

In his role at SkelRegen, Wozney brings more than 25 years’ experience in the pharmaceutical industry and scientific leadership to help grow the company as it leads the way in small molecule musculoskeletal tissue regeneration. “John brings a unique set of skills, experience and perspective to our business and we are delighted to have him join the team,” said Stephen R. La Neve, SkelRegen’s Co-Founder and CEO. “His accomplishments, reputation and understanding of our business will help SkelRegen bring our game-changing technologies to the bedside, and strengthen our business of small molecule musculoskeletal tissue regeneration.”

“John’s knowledge and proficiency in orthobiologics builds on the strength of SkelRegen’s value proposition,” said SkelRegen Co-Founder and Chief Medical, Science and Technology Officer, Scott D. Boden, M.D. Boden is Chief Medical Officer and Director of the Emory University Orthopaedic & Spine Hospital and Professor of Orthopaedics, Emory University School of Medicine. “As Director of Scientific Affairs, John will ensure that SkelRegen’s platform of small molecule technologies for transforming musculoskeletal care continues to provide cutting-edge solutions for those in orthopaedic surgery, trauma and plastic surgery.”

“I am thrilled to be part of the SkelRegen team,” said John Wozney. “As someone who has been in the industry for almost three decades, I am sure the work that SkelRegen is doing right now is leading the way in orthopaedic small molecule technology and I’m proud to be part of this revolutionary approach to musculoskeletal tissue regeneration.”

Wozney is the author of more than 150 peer-reviewed publications and is an inventor on more than 50 issued U.S. patents. He received both his A.B. and Ph.D. degrees in biochemistry from Harvard University and was a post-doctoral fellow at Massachusetts Institute of Technology.

The study was conducted to design and test small molecules that would enhance recombinant human bone morphogenetic protein-2 (rhBMP-2) responsiveness. The investigation used two models to test the ability of a small synthetic molecule to enhance bone formation in a rodent ectopic model and to determine whether an injection of that molecule accelerates callus formation in a rodent femoral fracture model. The final result showed that a single dose of the small molecule promoted bone healing in the ectopic model in conjunction with the occurrence of low-dose exogenous rhBMP-2, and in the femoral fracture model with the occurrence of endogenous BMPs.

SkelRegen is the first company to focus on newly identified small molecules that target different aspects of the musculoskeletal tissue formation pathway. The results of the study serve as further validation that by following established procedures, SkelRegen continues to build on its promise of being able to regenerate bone from scratch.

“While our work on musculoskeletal tissue regeneration is far from complete, this study exemplifies that research is continuing. In fact, recent laboratory data supports the stand alone enhancement of endogenous BMP’s, keeping SkelRegen at the forefront of small molecule musculoskeletal tissue regeneration,” said Stephen La Neve, SkelRegen’s Co-Founder and CEO. “Our partnership with Emory University makes it possible for us to be part of such revolutionary work.”

Boden said, “The process was long and arduous and would not have been possible without the computational design work of the Emory/VA team led by Sree Sangadala, PhD. These results further demonstrate how bone regeneration with small molecules will transform musculoskeletal care.”

SkelRegen is the first company to identify not one, but multiple small molecules that are osteoinductive and target different aspects of the musculoskeletal tissue formation pathway. All of the compounds are inexpensive to manufacture and some of the compounds are cleared for other uses by the FDA, so they already have acceptable safety and toxicity profiles in those applications. SkelRegen is using innovative methods and entities to simplify how medical professionals do their jobs and how patients receive care.

The article abstract is available for download on the Journal of Bone & Joint Surgery site here.

Dr. Boden was selected as one of this prestigious group because of his work and research focus on spine fusion, spinal disorders and bone regeneration. He holds at least TWENTY (20) patents for medical devices. You can read more on this prestigious honor at the Becker’s Spine Website.

Dr. Boden’s selection was also featured at AdvancingYourHealth.org, of Emory Orthopaedics and Spine Center.

“During the meetings we had the opportunity to talk with dozens of organizations including broad, traditional orthopedic and spine companies as well as more narrowly focused ortho-biologics firms,” said Stephen La Neve, president and CEO of SkelRegen.  “During our discussions at NASS, we found strong reinforcement that regenerative medicine is the principle focus right now within biologic medicine.”

Each year, NASS brings together leading spine authorities representing a multidisciplinary community of specialists, including: orthopedic surgeons, neurosurgeons, radiologists, physiatrists, pain management specialists, anesthesiologists, psychologists, chiropractors, physician assistants, nurse practitioners, nurses, physical therapists, researchers, administrators, and many other health care professionals invested in the advancement of spine care.

Specific to the SkelRegen process, La Neve added, “Within lab scenarios our novel chemical entities and multiple repurposed drugs have facilitated bone growth in non-bone locations from scratch and as such have the potential to change the face of spinal and orthopedic care.  We at SkelRegen are at the forefront of these discoveries.”

SkelRegen is the first company to focus on newly identified small molecules that target different aspects of the skeletal tissue formation pathway.  Several of its discoveries have been shown to be successful in blocking specific intracellular/extracellular inhibitors of BMPs, the key regulators of bone and soft tissue growth.  Blocking the inhibitors of BMPs dramatically enhances the body’s own stem cells and growth factors that lead to regeneration of bone and soft tissue.  Other discoveries also include molecules that can activate the BMP pathway directly.

The company anticipates addressing the unique clinical and economic needs of several major market segments, including Spine, Trauma, Scaffold & Bone Void Filler, Soft Tissue Repair, Orthopedic and Osteoporosis.

SkelRegen is the only company to have identified such compounds with all of these key attributes.

Stephen LaNeve, SkelRegen’s CEO, said the OTA meeting represents an outstanding opportunity to network with leading orthopaedic and pharmaceutical companies looking to expand their product portfolios into biologics as well as leading research companies looking to fill gaps in their own portfolio.

“It seemed like the timing could not have been better,” said LaNeve.  “Many of the companies attending OTA were either just starting or had already begun the process of laying out their 2013 – 2014 strategic plans.  Some of those companies were actively looking for biologics to expand their product portfolio and saw SkelRegen’s discoveries as highly attractive.  All in all, the excitement surrounding what we had to offer exceeded our expectations.”

SkelRegen will participate in several other trade shows serving the orthopaedic and pharmaceutical industries in Q4 2012 and Q1 2013.

SkelRegen results from a collaboration between Scott D. Boden, MD, Chief Medical Officer at the Emory University Orthopaedic & Spine Hospital and Professor of Orthopaedics, Emory University School of Medicine and Stephen R. LaNeve, former President of a multi-billion dollar Spinal & Biologics division of a leading global medical device company.

A major challenge in orthopaedic surgery, trauma, and plastic surgery is dealing with damaged skeletal tissues (bone, cartilage, ligament, tendon).  Current options are limited to biologically inactive space fillers or expensive recombinant proteins, peptides, and antibodies.  The best possible solution to this challenge would be a less expensive small molecule capable of regenerating skeletal tissues using the body’s own mechanisms; and by using compounds with known acceptable safety and toxicity profiles, the company expects to greatly reduce the time and expense needed for commercialization.

SkelRegen is the first company to focus on newly identified small molecules that target different aspects of the skeletal tissue formation pathway.  Several of its discoveries have been shown to be successful in blocking specific intracellular/extracellular inhibitors of BMPs (Bone Morphogenetic Proteins), the key regulators of bone and soft tissue growth.  Blocking the inhibitors of BMPs dramatically enhances the body’s own stem cells and growth factors that lead to regeneration of bone and soft tissue.  Other discoveries also include molecules that can activate the BMP pathway directly.

Boden, SkelRegen’s Co-Founder and Chief Medical, Science & Technology Officer says  “We discovered several small molecules that simply help the body’s own regeneration machinery do its job.  We are basically building bone from scratch now, with the expectation of building cartilage and other soft tissue in the near future.  This technology has broad application throughout the field of orthopaedics and holds promise for transforming musculoskeletal care.”  Dr. Boden oversaw the research team led by Emory Orthopaedics researcher Sreedhara Sangadala, PhD, that discovered the molecules.

The company anticipates addressing the unique clinical and economic needs of several major market segments, including Spine, Trauma, Scaffold & Bone Void Filler, Soft Tissue Repair, and Osteoporosis.

LaNeve, SkelRegen’s Co-Founder and CEO, adds, “These compounds are inexpensive to manufacture and many have already been cleared by the FDA for other uses, which means they have acceptable safety and toxicity profiles.  It’s very attractive from a development perspective.”

SkelRegen is the only company to have identified such compounds with all of these key attributes.

“We are very pleased to be able to commercialize this new technology,” says Todd Sherer, Executive Director of Emory’s Office of Technology Transfer. “I look forward to the results of this partnership and its potential to improve the lives of patients with musculoskeletal disease and injury.”

About SkelRegen

SkelRegen, LLC was formed in the state of Delaware in September, 2012.  The company maintains its headquarters in West Chester, PA.  For more information on the company, its products, or investment opportunities, please visit the company’s website at SkelRegen.com or call the company’s media contact directly.

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While it is unlikely anyone will eliminate bone fractures anytime soon, at least not in the way certain diseases have been eliminated or greatly reduced, imagine the benefits of simply reducing the amount of time needed to heal from a fracture.

Now imagine a small molecule capable of helping the body’s own mechanisms for generating bone that could be percutaneously injected into a skeletal fracture site to accelerate bone repair, decrease cast immobilization time, and reduce lost productivity. Just imagine the benefits to patients and employers all across the country. Percutaneous injection into healing fractures is an untapped market due to the lack of an injectable molecule at a reasonable price point.

It does not exist today. But if such a molecule could be identified, what would it be worth? How would its worth even begin to be measured? What percentage of those 2 million fractures every year in America alone would choose a speedier recovery?

SkelRegen has the only proven osteoinductive small molecules that can make bone from scratch demonstrated in pre-clinical studies today. SkelRegen is also working diligently to assess the market value of such a compound.

Contact SkelRegen to learn more

Of the tens of thousands of proteins known to man, only a select few of the BMPs are capable of making bone from scratch.  These BMP proteins have been around for quite a while in evolution, haven’t changed much in the last 1 million years, dating back to at least the fruit fly.  BMPs are present in all vertebrate animals.

While genetically engineered versions of BMPs have been capable of inducing bone formation, this version is very expensive to make and has to be used in much higher doses than natural in order to have an effect, increasing the possibility of side effects.

SkelRegen is the first company that has specifically designed small drug-like molecules to either enhance the function of the body’s natural BMPs or to potentially even mimic a BMP to fool the body into thinking the real thing is present.  The development of these small molecules has the potential to give surgeons the power to make bone heal, even in the toughest of places and the most difficult patients.

While some of these small molecules are brand new, others have already been cleared by the FDA for other uses and thus have an already defined and acceptable safety profile.  This is the ideal scenario to develop a game-changing technology to make bone from scratch, just like Mother Nature would have done.

Contact SkelRegen to learn more.