We participated in the RVC Hyperaccelerator and are therefore in the RVC network. We are interested in pitching at the Angel Capital Conference and following up with RVC following the RVC investor interest we received this fall.

Yes, the terms are negotiable. Importantly, the valuation was built off of several unique valuation models.

Convertible Note drafted, would also consider Preferred Equity Agreement.

$9 Million

TissueForm is raising a Seed round to aim to reach a total of $2.5M. TissueForm requires the OEDIT funding and $500,000 in matching funds to grow our team and presence (permanent office location) in Colorado. The full raise will advance NatruDerme to first-in-human trials to satisfy FDA medical device regulatory requirements. TissueForm has worked with several consultants to specifically budget all the elements necessary to reach the IDE submission to the FDA, including personnel and administrative/consultant business development needs, cGMP manufacturing development (sourcing, product processing, packaging, sterilization, accelerated aging, and verification/validation), producing a manufacturing batch for biocompatibility and toxicity testing, completing the essential FDA biocompatibility and toxicity studies in our Colorado based cGLP partners, implementing an eQMS at TissueForm, designing the clinical trial, and drafting/submitting an Initial Device Exemption (IDE) including the clinical plan to the FDA. The proposed tasks are estimated to take 12 months, but TissueForm budgeted 18 months to account for delays.

Jeanne Barthold, PhD (CSO/COO). Jeanne received her BS in Physics from Colby College (’14) and an MS (’18) and PhD (’20) in Mechanical Engineering from CU Boulder. She has business entrepreneurship experience from the Leeds Business School, led TissueForm’s involvement in the R2M program (based on NSF I-CORPS), the Innosphere incubator, and Ascent Accelerator and has been successful in commercialization workshops and pitch competitions. Jeanne is also completing a 9-month part time appointment as Director of the CU’s Center for Translational Research. Jeanne has led the operations and consultant relationships for TissueForm for the last two years, so is the ideal candidate to continue leading operations and execute on the current contracts needed to reach IDE approval.

Corey Neu, PhD (CEO): Corey is an established leader, mentor, and project manager having raised the funds for and led numerous million dollar projects. He is currently the Donnelly Family Professor of Mechanical Engineering at the University of Colorado Boulder. He has a broad research background in biomedical engineering and regenerative medicine (Brown, UC Davis, UC Berkeley, Purdue). When TissueForm secures the seed raise, Corey plans to take time away from the university to lead TissueForm until a new CEO is secured for the next phase of TissueForm growth. He is a world expert in imaging, biomechanics, and tissue engineering approaches for musculoskeletal and cardiac tissues, and is co-inventor of NatruDerme, which has been developed using non-dilutive NSF, DoD, and AIA POC funding.

TissueForm utilizes a lean model with established contractors to provide manufacturing (Viscus Biologics), regulatory filings (Proxima), clinical protocol development (Proxima), QMS support and experience (Proxima), Biocompatibility and Toxicity testing (Colorado State University PSRL), and financing structure (Richtr). Current active company advisors include: Tyler Novak, PhD, the Associate Director of device development at Gilead Sciences. Tyler helps to strategize and critique our product development and provides essential insight into the manufacturing transition. Dr. Jason Bloom, a well-known KOL in the injectables space and provides both an essential clinical perspective as well as a broad network of highly respected plastic surgeons. Nicole Glaros, MS, previous Chief Investment Strategy Officer at TechStars aids TissueForm in messaging and effective oral delivery. Timothy Worrell, JD, PhD, is a partner at BakerHostetler who informs our patent strategy. TissueForm is also currently a member of Creative Destruction Labs and has worked directly with eight different mentors who have experience in medical device entrepreneurship, strategic exits, and company and product development.

The major players in the reconstructive and cosmetic surgery space (Abbvie/Allergan, Galderma, Merz, etc.) often expand their product portfolios through acquisition. Therefore, TissueForm plans to pursue exit opportunities to these companies at the milestones where they have acquired others (post IDE, post PMA approval, or post sales). The best case exit is after IDE approval (milestone of this round) where Elastogen (a material based on a skin component elastin) was acquired by Allergan in 2018 for $95M upfront, and concluded as a $261M exit after achieving milestones. The more likely exit is just after FDA approval or with a small number of initial sales. (2) Luminera was acquired by Allergan Aesthetics (now a subsidiary of Abbvie) in 2020 for ~$100 million, after their filler was being sold in Israel/Brazil, but prior to FDA approval in the USA. (3) Vicept Therapeutics was acquired by Allergan in the Product Development stage for $75M up front with $200M in milestone-based earnings later. (4) SkinMedica was acquired by Allergan in 2012 for $375M after their line of skin care products was on the market.

TissueForm will require the initial $2.5M seed raise, and an additional $7M following IDE approval to get through clinical trials and FDA approval and begin initial sales. Therefore, we feel confident we can provide a return on investments to our earliest investors.

The key risks in the commercialization of NatruDerme include regulatory, IP, tissue allergies or reactions, and sales. (1) Regulatory: the risk of the product not being approved or the FDA having additional questions making the approval path longer. TissueForm has mitigated this risk by working with a regulatory consultant with experience in the space and by having a PreSubmission meeting resulting in the FDA confirmation of designation and the data they expect to see in the IDE and full submission. (2) IP: the risk of not having a large enough moat in a crowded landscape. TissueForm is mitigating this risk by completing a landscape analysis and freedom to operate search in addition to filing new patents to increase our moat beyond our first two strong technology patents that we are confident protect our innovation. (3) Tissue Allergies: one component of our product is porcine (pig) tissue, and some humans can have an allergic reaction to this. We are mitigating this risk by first removing all viral and cellular contents in manufacturing which removes the risk of immune rejection and significantly decreases allergy risk. We are also completing extensive toxicity testing and human allergy scanning as part of our IDE submission to inform doctors on the necessity of a skin sensitivity test prior to administering the product. (4) Sales: the risk is that in a market with powerful players we may struggle to get a foothold in the market. TissueForm is mitigating this risk by aggressively projecting and learning about the sales and marketing needs now, 3 years prior to FDA approval and sales. We have budgeted for and mapped out a regional sales strategy informed by research done with a Sales consultant and looking at the current entrance of new products in the space. We are additionally already pursuing strategics in the space to develop potential acquisition options or partnership opportunities.

NatruDerme is a cosmetic dermal filler, and like other fillers, it is a non-reimbursement out-of-pocket expense. Therefore, we sell directly to the physicians who in turn sell directly to patients in a cash model. There are very minimal indications where it can be covered by insurance and there is an existing hospital reimbursement code of G0429: Dermal filler injection(s) for the treatment of facial lipodystrophy syndrome (LDS) (e.g., as a result of highly active antiretroviral therapy).

TissueForm’s first product, NatruDerme, is an injectable biomaterial that will stay in the body for longer than 6 months, and as such is regulated as permanent. This means that NatruDerme will follow a class III medical device approval process via a PMA. Fortunately, the clinical trial is a relatively small number of patients (175-200), for a short amount of time (6 months), completed entirely in outpatient clinics which decreases the cost and timeline for the PMA immensely. TissueForm completed a Pre-Submission meeting with the FDA which confirmed and clarified the well-defined pre-clinical pathway of the required manufacturing controls and documents needed as well as the necessary biocompatibility and toxicity studies. The FDA confirmed the path that TissueForm was projecting and gave additional details to define the clinical trial. Therefore, TissueForm is confident that with a seed round we will be able to reach the milestone of IDE submission.

The manufacturing validation and verification is ongoing, including sterilization validation, and will run in parallel with the toxicity testing. The slew of required ISO 10993 preclinical tests will be performed on the pilot scale manufacturing batch and range from 3 days to 6 months. These values and timelines come directly from the consultant agreements TissueForm has to be able to execute immediately following funding. TissueForm is budgeting 18 months to complete all these tasks, but the time to completion with no hurdles is only 12 months. After IDE approval, typically only a 2 month FDA review, TissueForm will begin the multi-site clinical trial. The trial is only 6 months, with 2-3 months planned for recruitment (Our clinical partners have seen this in 1-3 months typically for fillers). Following the trial, and an additional 2 month PMA compilation period, the FDA review can take as long as 8-10 months until full PMA approval. Therefore the clinical trial phase, and all associated FDA tasks will take an additional ~18 months to complete based on the budgeted timeline and experience of our regulatory and clinical consultants.

TissueForm has an exclusive IP license agreement with Venture Partners at the University of Colorado Boulder for our patent portfolio. Our first patent application (“Methods and compositions for particulate and reconstituted tissues” PCT/US2018/051355), covers the broader biomaterial platform technology, including NatruDerme, where the material is applied to a defect and promotes recellularization to support tissue regeneration that mimics the surrounding healthy matrix. Our patent addresses the relationship of particle size and packing to tissue biomechanical properties. Our second patent application (“Particulate materials, formulations, and methods for tissue mimic in vitro and in vivo” PCT/US2021/072895) focuses on unique crosslinking chemistry between particles and natural macromolecules to form solid materials at body-temperature following injection. Finally, TissueForm has two trademarks for products in development: NatruDerme and NatruLage.

Our future patent strategy involves drafting defensive patents to increase our moat (currently drafting one) and filing further IP as R&D is advanced in future application areas. In the transition to manufacturing, we anticipate potentially filing critical process patents. Additionally, TissueForm is currently working with EnsembleIP (consultant) to complete a Freedom to Operate Search in our first application space, Reconstructive Surgery/Injectable Aesthetics, to ensure the freedom to market and sell NatruDerme. In the initial stages of the search, the team has identified no critical risks.

The NatruDerme product, supply chain, and production will become extremely scalable with the milestone completion outlined in this raise. Additionally, the TissueForm team is positioned to scale in the near term to achieve key milestones as we move toward FDA approval and commercialization. Following the Seed Raise, we will add a Manufacturing Operations and Quality Manager to help coordinate development, testing, and troubleshooting with the contract manufacturing firm and quality consultants we are working with. We are additionally planning to add a Regulatory Director to help guide pre-clinical testing to complete FDA submission and a fractional CFO (commitment agreement with Richtr) to ensure reliable accounting and projections for the Series A. The leadership team also plans to add a seasoned CEO 12 months after the raise to prepare for the transition to a series A and initial sales. Finally, we know it is critical to bring on and grow a sales and marketing team to engage with our clinical trial physicians and grow the regional customer base. In the future, TissueForm has a pipeline of future products utilizing our platform technology including a musculoskeletal repair material and 3D printing bioink. We established IP to allow the exit of the cosmetic vertical while enabling continued product development of other applications, if applicable.

TissueForm will adopt a regional sales approach following FDA approval, first selling in the Denver area (9% of the US market), followed by Southern California and then Miami. These three regions make up ~50% of the total $3.2B US dermal filler market. In Denver, the emerging cosmetic companies have 2-5 sales representatives, so TissueForm will match that and these initial sales reps will work to develop relationships first with the physicians in our clinical trials and then expand to the region using successful clinical data and influential KOL support. TissueForm will follow the same approach in each of the following regions, scaling the sales force to meet the standards in each region. From initial sales research with a local consultant Hilary Swan at RebelScout Consulting, we know that southern California is a large market, but it is also critically important in that region to have a strong and large sales force with previous experience in aesthetic sales. The KOLs and the momentum in our first sales region will be essential for expansion into the others. We will also follow another industry norm and will utilize both hosted trainings as well as bulk discounts to incentivize physicians to use NatruDerme and then advocate and educate peers about NatruDerme at national conventions (hosted by ASPS, ISPRS, etc.). The marketing and sales budget in this space is significant, and TissueForm has planned our future raise accordingly. TissueForm will also strongly pursue relationships now that could lead to an exit or partnership with an aesthetic company that already has an established sales and marketing pipeline.

TissueForm is advancing a Class III medical device, and therefore will have no sales until FDA approval in early 2026. However, TissueForm has ramped up fundraising at the end of 2022/early 2023. We had significant interest from Rockies Venture Club members at the end of the hyper accelerator in late 2022 and have since joined two other networks that are accelerating investment interest. First, the Creative Destruction Lab program in Toronto has introduced us to several angel investors who are following TissueForm. One has stated intention to be involved in a raise once we find a lead and several have scheduled second follow up meetings with us in the coming month. At the end of January we became a part of the Octane network which is an accelerator and capital/growth group based in Orange County, California -- the epicenter of aesthetic and cosmetic innovation. In the last few weeks since joining, we have pitched and had a booth at the Aesthetic Technology Forum, gotten several key well renowned KOL’s interested in joining our advisory board (ongoing conversations with three), had initial meetings with scheduled follow ups for two investment groups based there (Visionary Ventures and Tech Coast Angel Network), and had an initial meeting with a follow up schedule with one strategic partner who could be an investor as well (Bimini Medical Technologies). We additionally have a previous ~$500,000 of committed funds from MSAB Capital, the investment arm of Johnsonville Foods, once we are able to find a lead investor to set the terms.

Soft tissue loss is a result of injury and natural aging in the general population, and is specifically increased in injury settings, such as the military. This kind of damage from aging or injury leads to disfigurements where tissue volume is lost, impacting both cosmetics and function of the tissue. The augmentation of soft tissue is currently done with the invasive procedure of fat grafting or using off the shelf products called dermal fillers. Current popular fillers have 3 main pain points: (1) The most popular product lines, made out of hyaluronic acid (HA), provide only an inert gel structure that begins to degrade following injection due to natural enzymes in your body. This leads to a short lifespan of the filler leading to what patients refer to as ‘filler fatigue’, or dissatisfaction from needing repeat treatments to maintain confidence. (2) HA gels also lack any bio stimulation, which after several treatments can lead non-desirable puffy face look recently coined as ‘filler face’. (3) The alternative category of dermal filler products which overcome these problems are made up of plastic and synthetic materials. Importantly this means the current biostimulatory products are not reversible if common side effects arise. 75% of the physicians we spoke with either do not offer, or are hesitant to offer these alternative materials because they are not reversible. Physicians express a distinct need for natural materials that are both biostimulatory (and thus long lasting) and reversible.