The following was provided while participating in the 2023 Destination Startup® Showcase.
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What We Do
TissueForm is passionate about improving life for people affected by volumetric tissue loss by harnessing the natural, restorative power of tissue extracellular matrix. TissueForm’s biomaterial fills volumetric defects, integrates with host tissue and promotes healing.
Affiliated Institution: University of Colorado Boulder
Have we formed a company? Yes
Funding: Grant Funding, Other
Our Company and the Problem We Are Trying To Solve
Patients who desire corrective procedures for tissue loss using fillers must unfortunately choose between products that are (1) natural but quickly degrading, or (2) permanent but scarring. Instead, NatruDerme disrupts the tissue repair market by providing a ‘best-case’ and natural biomaterial that closely mimics the structure of skin, maximizes durability, and minimizes swelling and migration. TissueForm advances a novel injectable biomaterial, packaged in a dual syringe system, to address clinical problems in plastic surgery. TissueForm's biomaterials are composed of cross-linkable tissue and protein components which mimic natural tissue upon injection. TissueForm’s first product, NatruDerme is designed to closely mimic skin and is built from natural tissue components. NatruDerme has shown to immediately restore a youthful appearance with minimal swelling, provide desired tissue volumizing results during a visit to the clinic, and promote long-term healing. The key advantage is the performance of the biomaterial due to its unique composition. In pivotal comparative animal testing, NatruDerme outperformed major competitors in implant persistence, volume, swelling, and migration. Additionally, NatruDerme is the first product that uses tissue matrix in a dermal filler to mimic the skin, a distinct advantage over current market options like Juvederm and Restylane (hyaluronic acid, which quickly degrades), BellaFill (plastic, non-natural and scarring), or Radiesse (calcium hydroxylapatite, bone-like and scarring). The technology is protected by two patents, filed and held by the University of Colorado Venture Partners, with an exclusive license to TissueForm for markets including: plastic surgery/reconstruction/cosmetics, musculoskeletal repair, 3D bioprinting, and organ on a chip/3D cell culture.
Our Go-to-Market Strategy
NatruDerme will be sold and distributed through the existing, and well-defined, B to B sales model. The market for cosmetic and reconstructive surgery is $89 billion, and the Serviceable Obtainable dermal filler Market (SOM) is $8.8 billion. Our Serviceable Addressable Market (SAM) in the first 3 years, following TissueForm’s regional sales approach is $1.57B. The distinct advantage to NatruDerme is that it is a filler which has demonstrated a superior performance entering a well-defined market. The most popular fillers today are Juvéderm and Restylane, both hyaluronic acid biomaterials. However, these fillers break down in the body and do not provide a long-term healing response. Alternatively, fillers including Radiesse (synthetic bone-like particles) and Bellafill (plastic beads) are semi-permanent, lasting longer, but lead to scarring and an inflammatory response, which is non-natural and irreversible. Patients need natural and reversible products that are long lasting and promote regenerative healing. NatruDerme is composed of flowable natural tissue materials which immediately correct volume loss with minimal swelling, ensuring the patient leaves the clinic with desired results. TissueForm is the first company to use decellularized tissue matrix in a dermal filler to closely mimic the protein content of tissues in the body. The major players in the reconstructive and cosmetic surgery space (Abbvie/Allergan, Galderma, Merz, etc.) often expand their product portfolios through acquisition. Therefore, TissueForm also plans to pursue exit opportunities to these companies at the milestones where they have acquired others (3 distinct points along commercial development).
How We Will Generate Revenue
Aesthetic centers and private clinics are small practices with only 1-2 surgeons, and we will sell our one-time use, sterile-packaged syringes directly, B2B. Following the industry standard, NatruDerme will be sold to private aesthetic clinics for $650/product. The dermal fillers at private clinics have no insurance reimbursement considerations. Clinics may competitively price NatruDerme at $1300 per syringe and provide a superior product to their patients that lasts longer and swells less than current leading fillers (Juvederm, Restylane), and creates a natural repair unlike synthetic products (Radiesse, BellaFill). Current fillers cost patients $700-$2000, and costs providers $350-$1000. Projected NatruDerme margins exceed 85% and we anticipate these margins will increase with scale. TissueForm's business model is to sell first to our clinical trial sites and their partners in two regions: CA and CO, initially selling to just 12 clinics. With an assumed 4 patients/month at each clinic initially, revenue is projected as $1.2M in the first year. We will then expand within these regions and to a third region (South Atlantic) with additions in our sales force, centered on Florida. Sales will then focus on capturing an increasing portion of these markets. These three regions have a substantial portion of the dermal filler specific market: Mountain Region (9.4%), Pacific Region (17.1%), and South Atlantic region (22.6%). TissueForm recognizes the need to develop and maintain close relationships with our customers and thus we must have regional staff able to assist clinics at very short notice.
How We Will Benefit From Destination Startup®
Destination Startup will benefit TissueForm in several ways. First and foremost, TissueForm is currently raising a $2.5 million seed round. While we have secured soft commitments for ~30% of the total raise, Destination Startup can help us gain visibilty to find a key lead investor. The raise will advance NatruDerme through an Initial Device Exemption (IDE) approval by the FDA. Reaching this milestone will significantly derisk the commercial potential of NatruDerme and enable TissueForm to begin clinical trials. The current funding round will be allocated towards manufacturing specializing in processing, packaging, and validating porcine derived medical devices -- TissueForm’s main functional component. It will also be allocated towards the completion of toxicity studies required by the FDA, confirmed in TissueForm’s recent Pre-Submission meeting. With funding, TissueForm will begin scale-up manufacturing immediately and accelerate the studies that will directly impact the speed of NatruDerme market entry. Additionally, TissueForm plans to expand our management team following the seed raise, as we look towards a Series A round to fund clinical trials. The potential networking opportunities that Destination Startup provides, will expand our network to connect us with potential leadership candidates right for our company, team, and vision.
The TissueForm team includes: (1) Corey Neu Co-Founder, CEO, received training from Brown University, UC Davis/Berkeley. He is a Donnelly Family Professor at CU Boulder. He has raised >$14M in competitive funding to support biotech research and commercialization, with 10 submitted or issued patents. He has helped the company secure non-dilutive funds. (2) Jeanne Barthold, Co-Founder, CSO/COO, received her BA from Colby College, followed by an M.S. and PhD from CU Boulder. She has completed extensive commercialization training through the Leeds School of Business and Venture Partners at CU. She has led numerous biotech studies and project management activities to develop novel biomaterials in benchtop and in vivo animal models. Finally, she has played a pivotal role in raising non-dilutive funding through business plan competitions to support TissueForm commercialization. (3) Juliet Heye recently joined the team to complete lab based R&D for follow on applications to the flagship NatruDerme product, especially in 3D bioprinting. In her first year, she took a venture launch class at Leeds, participated in Starting Blocks, and pitched in the NVC. We are able to keep a lean team with technical founders because we utilize a strong network of contractors who enable the completion of the tasks outlined in our raise. TissueForm has an active contract with Viscus Biologics: a manufacturer specializing in porcine-based medical devices with an established QMS. Other active consultants include Proxima Medical (regulatory path and clinical trial) and PSRL at CSU, A GLP certified facility at CSU that will complete toxicity studies.