Patients who desire corrective procedures for tissue loss using fillers must unfortunately choose between products that are either: (1) quickly degrading, or (2) semi-permanent, but also synthetic leading to scarring and non reversible repair if complications arise or the patient is not satisfied. Plastic surgeons, RNs, and injectors who provide these procedures desire fillers that are long lasting and promote biological activity in the implant (similar to semi-permanent fillers), but also are reversible and natural. 

Using solely non-dilutive funds to date, we have already accomplished multiple critical milestones for our industry (see segmented list below).

Technology and IP Development: (1) Patent submitted covering particulated tissue, with special emphasis on the packing density (2018), (2) Patent submitted for new biomaterial chemistry and delivery system (2021), (3) Company formation (2019, Delaware C-Corp, company registered in Colorado), (4) In 2019, completed a 60-animal POC study that identified safety and potential of NatruDerme as a dermal filler, (5) In 2022, completion of long-term, pivotal animal testing that compared NatruDerms directly against competitor products (Restylane, Radiesse, Juvederm, BellFill), and evaluated swelling, migration, degradation, and biostimulatory healing in the implant, (6) Signed exclusive license from CU Boulder for TissueForm’s patent portfolio in a wide range of use cases (2022), (7) Invited to host a booth and pitch at the Aesthetic Tech Conference in Orange County, CA. Attended in late January 2023.

Funding: (1) awarded AIA POC funds (2018), (2) Won $26,500 in New Venture Challenge with 3rd place overall, 1st place R&D and 1st place female founder tracks (2019), (3) $1.2M DoD lab grant awarded to further develop and test the biomaterial technology (2019), (4) 1st place in UNC Monfort Entrepreneurial Challenge (2021), (5) awarded AIA proof of concept funds for new 3D printable technology (2021). (6) Spring 2023 awarded AIA Early Stage Capital and Retention Grant ($250,000)

Entrepreneurship Programs: (1) Creative Destruction Labs (highly competitive 9-month milestone based mentorship and business development program, Biomedical track – currently involved), (2) Acceptance into Octane strategic growth advisory group (early 2023) to enhance investment opportunities (see support letter), (3) Starting Blocks, (4) Research-to-Market ICORPS customer discovery workshop.

Incubator/Accelerators: (1) Rockies Venture Club HyperAccelerator, (2) Innosphere Incubator Graduate, (3) Ascent Accelerator, (4) Acceptance into Octane Incubator in early 2023.

Team: (1) In 2021, Jeanne Barthold, CSO/COO, joined TissueForm full-time to run operations and business development after completing her PhD, (2) In 2022, Juliet Heye and Dhalia Ortiz were added to the TissueForm team in R&D to enable the founding team to focus on business development and fundraising. (3) In 2021 and 2022, TissueForm hired several consultants to expand the team: Proxima Medical (regulatory drafting and negotiation, clinical trial budgeting and management/facilitation, QMS onboarding and management), RebelScout consulting (CO based fractional sales leadership), Viscous biologics and Lifecore Biomedical (sourcing, manufacturing, and distribution), Richtr Financial (CO based early ProForma development, will be fractional CFO post funding). (4) In early 2023, compilation of candidate list and initial interviews began for formal board of advisors (including clinical KOL’s, product development experts, and aesthetic business development executives with a history of exits in the space)

Regulatory: (1) In 2020, defined an FDA pathway with regulatory consultant Hogan Lovells, (2) Pre-submission meeting in June 2022 with FDA leads to FDA confirmed Class III medical device pathway and associated milestones. (3) Early 2023, completed QMS assessment with Proxima consultant to define electronic onboarding (start following funding).

Manufacturing: (1) Completed MVP biomaterial and syringe delivery system prototype (2021), (2) Design freeze on MVP material for testing and transition to manufacturing (late 2021), (3) In early 2022, elected Viscous Biologics and Lifecore Biomedical as cGMP manufacturing facilities based on their specialization in acellular tissue products and HA production. (6) By the end of 2023, completion of ‘Define Phase’ with cGMP manufacturer, move into ‘Discover Phase’ (pilot scale manufacturing, phase 2/4 in manufacturing development).

NatruDerme will be sold and distributed through the existing, and well-defined, B to B sales model. We will sell directly to private aesthetic clinics for $650/product (1cc). Clinics may competitively price NatruDerme at $1300 per syringe, and provide a superior product to their patients that lasts longer than current leading fillers (Juvederm, Restylane), and creates a natural repair unlike synthetic products (Radiesse, BellaFill). Current fillers cost patients $700-$2000, and costs physicians $350-$1000. Projected NatruDerme margins exceed 85%. 

The overall market for cosmetic and reconstructive surgery is $89 billion, and the market specifically for fillers globally is $8.8 billion. In the US, dermal fillers are in a $3.2 Billion market. Our Serviceable Addressable Market (SAM) in the first 3 years, following TissueForm’s regional sales approach (launching in 3 regions that make up 50% of the US market) is $1.57B. In the mountain region alone, dermal fillers are a $300 million market. 

TissueForm was founded with the passion to use science and technology to help patients who suffer from volumetric tissue loss causing them pain or a decreased quality of life. The co-founders have worked together on numerous projects since 2015, and are excellent at driving progress while knowing our weaknesses and surrounding ourselves with people that can help fill those gaps. The TissueForm team is hardworking, coachable, agile, and committed to making every dollar go as far is it can. While our core team is still small due to our current fundraising stage, we work with a variety of consultants and start-up communities to ensure efficient and smart growth of our company and product. 

Our technology is special because it is a platform technology with several years of research backing up multiple use cases for the technology. At its core, the technology utilizes the natural and impressively complex structure of tissues (cartilage, skin, muscle, etc.) and through engineering, we enable this structure and biological signals to be used as a repair material to regenerate realistic and functional tissues in areas of tissue loss and injury. The company and team are special because we are very motivated to move the technology from the lab to the patient. We know the regenerative potential of the material, and have advanced the business and product development to this seed raise using only grants and other non-dilutive funds. We are excited to grow the business and the team and are ready to execute on the well defined milestones to commercialize our first product. As we grow, we are committed to building a diverse team, both in our leadership team as well as in our board structure. As a majority female-owned company, we value diverse backgrounds and skillsets and know that the best companies are built from diverse teams. 

After FDA approval, TissueForm will sell first to clinical trial partners and their networks, as the physicians will already have confidence in our product. Sales will expand regionally with staggered market entry in Denver, LA and Miami (~50% of US market). In each region, the sales projections will ramp over the first 6 months, based on comparable companies. Sales will focus on clinics with a desire for innovation and prestige. TissueForm is already building relationships with KOLs in the aesthetic space to present and train colleagues on behalf of TissueForm. We know that regional sales allows us to build trust, which is vital in this industry. Importantly, there are early exit or partnership opportunities that we will pursue (i.e. to Abbvie, Merz, Bimini) at FDA approval, based on comparable companies and exits.