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Skelegen, LLC

Biotech development company

Presenter: Sigmund Kulessa MD, MBA, President of Skelegen


Monday, October 12, 2015

Embassy Suites, Chesterbrook, Pennsylvania (directions)




Skelegen LLC is developing a novel, targeted osteoinductive agent for the enhancement of bone growth in spinal fusion procedures.  The product consists of an osteoconductive bone graft scaffold paired with Jagged-1, a protein known to stimulate bone growth.  This combination provides the power of a biologic with a greatly enhanced safety profile when compared to competitive products.


Bone Morphogenetic Protein – 2 (BMP-2), also known as Medtronic’s Infuse, is the only osteoinductive biologic on the market that is approved for spinal fusion.  Originally a wildly successful product with peak sales ~ $900 Million, off-label marketing and a number of safety concerns including exuberant ectopic bone formation and in some cases death led to a sales slide to the current ~$470 Million per year.  This sizeable known void in this market, along with the fact that surgeons still want to use a biologic with osteoinductive properties in spite of safety concerns, both point to an excellent opportunity for a fusion technology that grows bone with an enhanced safety profile.


Skelegen’s technology utilizes the Notch Signaling pathway ligand, Jagged1, which has demonstrated to potently induce osteoblast differentiation and bone mineral production in vitro and in vivo.  Jagged 1 is not part of the BMP family and is not a soluble growth factor.  Instead it produces its effects as a surface bound cell to cell signaling molecule.  Jagged1 must be adsorbed to a surface to induce a functional signal; ligand that is free-in-solution or that diffuses from the implant location is inert.  This greatly enhanced safety feature does not depend on the design or manufacture of the device; it is a fundamental aspect of the biology.  Jagged1 can likely be paired with any commercially available scaffold and Skelegen currently has positive in vivo data with Jagged1 paired with a commercial scaffold.  The Jagged1 / biomaterial combination will be regulated through the PMA pathway as a combination device.



3 Major Issues


  1. The team is 99.9% certain that our combination product will be regulated as a device and go through the PMA pathway, with a good amount of input from CBER along the way.  We’re looking for advice on managing the combination product process with the FDA; Best practices? Pitfalls?
  2. As with any ‘growth factor’ approach to amplifying the body’s ability to heal, there is a theoretical cancer risk associated with using Jagged-1.  What is the best way to handle this issue?  Which specific studies should we perform and when should we do them?
  3. Is the company fundable at this point?  What changes to the company / technology / pitch would increase our chances of securing funds?





6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)

8:00 - Sigmund Kulessa MD, MBA, President of Skelegen, will deliver the Company's "Elevator" Pitch to the Group

8:20 - A Panel will address three major issues crucial to helping the Company reach the next level.

9:00 - Open discussion: members and guests



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Contact: Peter van der Kam, | (610) 296-8086




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Pharmaceutical Consulting Consortium International, Inc., or (610) 296-8086

Meetings Held at Embassy Suites - Valley Forge

888 Chesterbrook Blvd, Chesterbrook, Pennsylvania 19087

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