As the first company to advance personalized, stem cell-based skeletal implants into Food and Drug Administration (FDA) cleared clinical trials, EpiBone is redefining orthopedics with living implants that seamlessly integrate and naturally remodel over time. EpiBone uniquely grows patient-specific bone and cartilage from a patient’s own stem cells, pairing artificial intelligence (AI) driven design with three-dimensional (3D) fabrication to achieve a precise anatomical fit. EpiBone has pivoted its go-to-market (GTM) strategy to focus on medical tourism supported by developments in the United Arab Emirates (UAE) and Thailand.

Location
New York, NY & Abu Dhabi, UAE
Investment Timeline
Founder Discussion
September 8, 2025
Commitment Deadline
September 19, 2025
Funding Due
September 26, 2025

Investment Opportunity

This opportunity is reserved for our existing member investors that have invested in EpiBone’s previous 2017 and 2021 rounds. For clarification, this round is not available to all Plum Alley members.

EpiBone is raising an insider-led $4M Series A-1 financing at a $105M pre-money valuation, co-led by Kendall Capital Partners and Tech Council Ventures. This round introduces pay-to-play mechanics and a progressive Bonus Preferred share structure, supporting its new strategic pivot into medical tourism to further the bone stem cell technology we previously invested in.

Key terms for the pay-to-play round with a minimum Plum Alley Ventures Company SPV investment of $250,000 include:

  • Participation terms: As per the pay-to-play terms, all investors get converted from Preferred into Common on a 10:1 basis. And then reconverted into Preferred share class on a 1:10 basis with the minimum investment participation.
  • Bonus Preferred eligibility: At the $250,000 SPV investment level, Plum Alley Ventures Company qualifies for 4 Bonus Preferred shares for every Series A-1 Preferred share purchased as an investment incentive for existing investors.
  • Liquidation preference: Participating investors will maintain a senior status in liquidation to all other stockholders.

Please note that for our member SPV to participate, we will need a minimum of $250,000 in member investment commitments. If this threshold is not reached, Plum Alley Ventures Company reserves the right not to participate in the current Series A-1 pay-to-play round, resulting in our current Preferred shares converting to Common on a 10:1 basis.

More information on the terms of the round can be found in the ‘Capitalization & Current Raise’ Section below.

INVESTMENT TIMELINE

‍Virtual Company Presentation

Monday, September 8th, 2025

12:00 pm ET // 9:00 am PT

RSVP to Google Calendar invite

Call details available here

Final Investment Commitments Due

Friday, September 19th, 2025

We will take commitments on a rolling basis. To secure your allocation, please submit final commitments here.

Funding & Documents Due

Friday, September 26th, 2025

At the end of the commitment period, you will receive details regarding closing documentation and wiring instructions via Carta.‍

The Company's confidential financing documents and diligence materials are available for review in Carta. Please request access to data room materials at the top of the page. All documents are confidential and not for further distribution. If you have specific questions or are interested in investing in EpiBone, please contact us and submit your investment total here. Given the Syndication timeline to meet EpiBone's Series A-1 closing date, if the Plum Alley Ventures Company Syndicate does not meet certain milestones it may not move forward.

Key Updates Since the Last Round

EpiBone has advanced its platform across bone, joint, and cartilage with key milestones in three strategic markets:

  • UAE: Building a Good Manufacturing Practice (GMP) facility, initiating Phase III EB-CMF trial, and launching the Living Joint Replacement Program.
  • Thailand: Progressing to first-in-human EB-iAC implantations, positioning injectable cartilage for accelerated commercialization.
  • US Military: Secured a $1.25M non-dilutive contract with the US Air Force’s (USAF) 59th Medical Wing via AFWERX to expand EB-CMF into mandible and dental applications.

The company is now focused on development and growth of medical tourism in these markets, with the UAE and Thailand as strategic anchors.

Proceeds will fund expansion in the UAE, including a GMP facility in Abu Dhabi, a Phase III program, and the Living Joint Replacement Program. Capital will also advance three EB-CMF implantations with the USAF, complete injectable cartilage EB-iAC human implantations in Thailand, and secure osteoporotic bone (EB-OP) IND approval in the UAE. The UAE and Thailand are top medical tourism destinations, which supports cost-recovery sales during Phase II and accelerates time to revenue ahead of FDA approval.

Co-founded by Chief Executive Officer (CEO) Dr. Nina Tandon (PhD, Columbia) and Chief Science Officer (CSO) Dr. Sarindk “Ik” Bhumiratana (PhD, Columbia; Postdoc, Columbia), EpiBone pairs deep tissue-engineering expertise with foundational intellectual property (IP) for its living bone and cartilage platform. Their track records, supported by a board and advisors that include Moderna co-founder Robert Langer, PhD and KKR’s co-founder Henry Kravis, underpin strong scientific and execution credibility.

Introduction to EpiBone

In our lifetime, three out of four people will live with parts of their bodies they were not born with. Nowhere is this more evident than in orthopedics, where more than 10M bone and cartilage reconstruction procedures are performed annually in the United States (US) alone. Current approaches, such as metal hardware, synthetic substitutes, and scarce cadaver grafts, offer structure but fall short on true biological integration. At the same time, advances in regenerative medicine and tissue engineering over the past decade have opened the door to solutions that heal, remodel, and endure.

EpiBone is pioneering that future. As a clinical-stage regenerative medicine company, EpiBone engineers living bone and cartilage customized to each patient using their own stem cells. By delivering patient-specific biologic implants that integrate and remodel over time, the company aims to reduce the complications, limitations, and failure rates of today’s standard interventions. EpiBone brings together 3D imaging, computational design, advanced biomaterials, and perfusion bioreactors to create functional tissue that is ready at implantation. Its platform spans multiple indications, positioning the company to address high-burden conditions in the jaw, knee, hip, and other joints.

EpiBone’s closed-loop tissue engineering platform mimics natural skeletal development. Computed tomography (CT) imaging defines an exact anatomical scaffold, autologous adipose-derived stem cells are expanded and seeded, and perfusion bioreactors deliver oxygen, nutrients, and mechanical cues to mature living grafts. This technology underpins a pipeline that covers bone, joint, and cartilage products:

  1. EpiBone Cranio-Maxillofacial (EB-CMF): Patient-specific bone grafts for jaw and skull reconstruction.
  2. EpiBone Osteochondral (EB-OC): Living bone-cartilage composites for load-bearing joints such as the knee.
  3. EpiBone injectable Articular Cartilage (EB-iAC): An off-the-shelf injectable for focal cartilage defects.

The company has already completed early clinical work for EB-CMF in the US, holds an Investigational New Drug (IND) clearance to begin EB-OC Phase I/IIb trials in the US, and is preparing to initiate EB-iAC human studies in Thailand.

To accelerate adoption and revenue, EpiBone is executing internationally through hubs in the UAE and Thailand. The UAE provides access to destination orthopedic care, strong intellectual property protection, and modern logistics, and EpiBone is pursuing conditional approval, building GMP capacity in Abu Dhabi, and launching the Living Joint Replacement Program. Relationships include Hub71, Cleveland Clinic Abu Dhabi, Burjeel Holdings (which has committed $2.5M in in-kind support for an osteoporosis trial), and the UAE Department of Health. Thailand provides the second anchor for EB-iAC, with leading hospitals, experienced contract research organizations, and a thriving medical tourism sector. Together, these hubs allow earlier patient access, cost-recovery revenue, and strategic partnerships, including planned EB-CMF implantations with USAF.

EpiBone’s regulatory and financing roadmap is built to convert international traction into lasting US leadership. The company’s global trials are being designed with FDA-aligned endpoints, and EpiBone plans to present this data in a Type C meeting in late 2026 or early 2027 to accelerate the US approval pathway. Its differentiation lies in full anatomical matching, the use of autologous stem cells, and a platform adaptable across multiple skeletal sites - advantages that clearly distinguish EpiBone from drug therapies, non-personalized synthetics, and single-indication cartilage products. With multiple Investigational New Drugs (INDs) already cleared, human data advancing, and insider participation in the current Series A-1 financing ahead of a targeted Series B following the Type C meeting, EpiBone is well positioned to lead the next era of regenerative skeletal medicine.

To learn more, watch the recent update presented to Plum Alley Ventures Company by co-founders Nina Tendon, PhD and Ik Bhumiratana, PhD below.

Highlights‍

* Urgent Unmet Need and Market Pull: Orthopedic regeneration faces clear supply and outcomes gaps. ~2.2M procedures use bone grafting each year with roughly 500K in the US while only ~3K fresh osteochondral allografts are available annually. In the US, more than 30M adults live with osteoarthritis. EpiBone targets this demand with patient-matched, living grafts that aim to integrate and remodel.

* Ex-US Launch Engine: EpiBone is building a clinical-commercial beachhead in Abu Dhabi to accelerate time to first revenue. Relationships include Hub71, Cleveland Clinic Abu Dhabi (exploratory), Burjeel Holdings (letter of support for $2.5M in-kind for the osteoporosis trial), and the UAE Department of Health for conditional approval and grants. Thailand anchors EB-iAC first-in-human work with established CRO infrastructure and medical-tourism logistics.

* Clinical and Regulatory Momentum Across Three Programs: EB-CMF (autologous bone) has completed a US Phase I/IIa; EB-OC (osteochondral autograft) holds US IND clearance to begin a Phase I/IIb; EB-iAC (injectable cartilage) is advancing to human implantation in Thailand. The mix of autologous and allogeneic products expands addressable use cases from cranio-maxillofacial reconstruction to focal knee lesions and low-grade cartilage defects.

* Differentiated Tissue-Engineering Platform: The platform emulates developmental biology: CT-guided design, a custom scaffold, and adipose-derived stem cells matured in perfusion bioreactors that deliver oxygen, nutrients, and controlled mechanical cues. The result is living, patient-specific bone, cartilage, or osteochondral grafts built to fit precisely and remodel in vivo, addressing the fit, durability, and supply limitations of synthetics and cadaver allografts.

* Defense and Regulatory Catalysts: The USAF is sponsoring EB-CMF implantations for craniofacial repair, creating high-need validation and an early customer channel. International trials in the UAE and Thailand are being designed with FDA-aligned endpoints, with plans to present foreign data at a future Type C meeting. The UAE Department of Health process and Burjeel’s in-kind support further de-risk execution and early adoption.

Background Overview

EpiBone’s platform recreates key steps of skeletal development to grow living grafts that match each patient’s anatomy. For personalized bone and osteochondral constructs, the workflow begins with a CT scan of the defect and a small adipose biopsy to isolate mesenchymal stem cells. Engineers design a patient-specific scaffold and matching perfusion bioreactor, then culture the cells under controlled oxygen, nutrients, and mechanical loading to drive maturation. Typical culture time is about 3 weeks for bone and about 4 weeks for cartilage, at which point the graft is ready for implantation.

The platform supports three modalities. EB-CMF is a patient-specific bone graft for cranio-maxillofacial defects that has shown maintenance of structure, integration, and vascular infiltration in large-animal studies prior to human trials. EB-OC is a bone-cartilage composite grown as cartilage on a bone scaffold for joint repair. EB-iAC is an injectable, off-the-shelf cartilage product with scalable manufacturing and multi-month shelf life for on-demand use and easy shipping.

What makes it different

  • Full anatomical matching of scaffold and shape using patient CT and 3D design, enabling precision fit at the defect site.
  • Autologous stem cells for EB-CMF and EB-OC to reduce immune risk and support long-term integration. EB-CMF explicitly uses the patient’s own adipose-derived cells, and the company highlights non-immunogenic acceptance and integration for its cell-based grafts.
  • Platform adaptability across skeletal sites, from head and jaw to knee, with expansion potential into additional joints and connective tissues. The injectable cartilage format travels well and can be stocked on demand, supporting flexible scheduling and early adoption.

EpiBone’s grafts are living and designed to integrate with surrounding tissues, unlike metal or ceramic hardware that provides structure but not regeneration. The company’s IP stack covers bioreactors, osteogenic and chondrogenic media, MSC processing, next-generation scaffolds, automation, injectable cartilage compositions, and delivery tools, creating a defensible process and manufacturing moat.

Two FDA-cleared INDs enable ongoing progression of EB-CMF and EB-OC, while EB-iAC advances internationally with FDA-aligned endpoints. This staged path generates early clinical experience and revenue outside the US while building the dataset for the US approval path.

Technology & Product

EpiBone’s platform emulates developmental biology: imaging defines the exact anatomy, a custom scaffold is fabricated, and the patient’s adipose-derived stem cells are seeded and matured in a perfusion bioreactor that delivers oxygen, nutrients, and controlled mechanical cues. This produces living, patient-specific grafts for bone, cartilage, or composite osteochondral repair.

How The Platform Works

  1. Imaging to Design: A CT scan is converted into a 3D model of the defect, which guides the manufacture of a geometry-matched scaffold so the graft fits like a puzzle piece at surgery.
  2. Cells and Scaffolds: For autologous bone, adipose-derived stromal or stem cells are harvested from a small lipoaspirate and expanded. Foundational work demonstrated shaping decellularized bovine trabecular bone via image-guided micromilling and then seeding with the patient’s cells to form immature living bone for implantation.
  3. Bioreactor Maturation: Custom perfusion bioreactors drive deep oxygen and nutrient delivery and apply controlled mechanical cues that support lineage commitment and extracellular matrix deposition. Autologous adipose-derived cells were perfused for three weeks to generate grafts ready for implantation. More broadly, the bioreactor principles aim to mimic the in vivo niche to accelerate functional tissue development.
  4. Osteochondral Engineering: For composite cartilage-and-bone, the goal is a hyaline-like cartilage layer bonded to a load-bearing bone base. EpiBone’s clinical description of EB-OC specifies a living cartilage layer attached to a bone scaffold; academic bioreactor literature supports dual-zone perfusion and mechanical cues to drive chondral and osseous maturation for plugs.
  5. Allogeneic Option and Logistics: For cartilage indications, EpiBone uses banked mesenchymal cells to create allogeneic living products. An injectable format is designed for off-the-shelf use with long component shelf life that supports scheduling and distribution.

Why It Matters

The approach targets three long-standing pain points in surgery: precision fit, biologic integration, and supply. Patient-matched geometry reduces intra-op carving, living tissue supports remodeling and long-term durability, and engineered constructs avoid the severe scarcity of cadaver osteochondral allografts.

Product Portfolio

  1. EB-CMF: Patient-specific cranio-maxillofacial bone (autologous).
    Indicated for facial reconstruction after trauma, congenital defects, or tumor resection. The process uses the patient’s CT for shape, adipose-derived cells for biology, and perfusion maturation prior to surgery. FDA cleared the first-in-human Phase 1/2 study in 2019, and team publications detail image-guided scaffold shaping and 3-week perfusion culture prior to implantation.
  2. EB-OC: Engineered osteochondral graft for focal knee lesions (allogeneic).
    A living cartilage layer integrated to a bone scaffold for high-grade focal defects in otherwise healthy joints. FDA granted IND clearance in July 2023, and the registered clinical study describes a tissue-engineered osteochondral graft with living cartilage attached to a bone scaffold that aims to regenerate hyaline cartilage anchored to regenerated bone.
  3. EB-iAC: Off-the-shelf injectable cartilage (allogeneic).
    Banked stem-cell-derived condensed mesenchymal cells are combined with a hydrogel carrier for minimally invasive treatment of low-grade cartilage lesions that do not involve bone. Company materials indicate component storage up to 2 years, enabling on-demand use and simplified logistics for trial sites and future customers.

Takeaway

EpiBone runs a digital, traceable workflow from imaging through scaffold fabrication and perfusion bioreactor culture that enables scale-out manufacturing of personalized or batch allogeneic products. By uniting CT-guided design with autologous or banked cells in perfusion bioreactors, the platform aims to deliver living skeletal grafts that fit precisely, integrate biologically, and expand access where donated tissue is scarce. The EB-CMF, EB-OC, and EB-iAC programs translate this into focused indications where each element of the technology provides a practical advantage in the operating room and beyond.

Business Model & Traction

EpiBone operates a staged commercialization plan that starts ex-US and scales into the US after approval. Near term, the company plans conditional clinical use in the UAE and Thailand so it can treat patients during Phase 2 and later, generate early revenue on a cost-recovery basis, and collect FDA-aligned outcomes while it builds a GMP site in Abu Dhabi. Post-approval in the US, EpiBone intends to price against complex reconstructive procedures and pursue coverage with evidence packages built from its international and US data. The platform supports both autologous, patient-specific grafts for bone and osteochondral repair and an allogeneic injectable cartilage product that can be stocked and scheduled flexibly.

The UAE is the near-term anchor given its position as a global health-care hub. Dubai alone welcomed more than 691K international health tourists in 2023, generating over AED 1B (~$280M) in spending. The country offers strong intellectual property protection, modern logistics that simplify cold-chain distribution, and progressive regulators open to conditional approval. EpiBone expects the UAE to enable revenue three to five years faster than a US-only path, while expanding the effective total addressable market (TAM), treating more patients sooner, and reducing equity capital requirements.

Thailand provides the second anchor for EB-iAC clinical translation. Ranked consistently among the world’s top medical tourism destinations, Thailand attracted 3.5M foreign patients annually pre-COVID and has rebounded strongly with government-backed initiatives. The country combines leading university hospitals, established contract research organizations (CROs), and a reputation for affordable, high-quality care. For EpiBone, this ecosystem offers efficient patient recruitment, cost-effective trial execution, and a natural launchpad for its injectable cartilage product.

Together, the UAE and Thailand create an international engine that enables earlier patient access, cost-recovery revenues, and FDA-relevant data collection. These efforts are designed to generate pre-Biologics License Application (BLA) revenue abroad, then scale domestically once FDA approval is secured. A BLA is the formal submission to the FDA requesting authorization to market a biologic in the United States, supported by clinical, manufacturing, and quality data.

Key achievements include:

  • FDA IND clearance and first-in-human Phase 1/2 initiation for EB-CMF in mandibular reconstruction, establishing initial US clinical credibility.
  • IND progression for knee osteochondral repair with EB-OC, with an active study entry on ClinicalTrials.gov.
  • Publicly described allogeneic injectable cartilage program (EB-iAC) featuring long component shelf life and on-demand use, which supports ex-US hub distribution.
  • Abu Dhabi presence within Hub71, validating the UAE hub strategy and local ecosystem support.
  • Core technology and bioreactor process publicly profiled by the company and independent outlets, reinforcing the patient-specific living-tissue value proposition.

Near-term milestones (18-24 months):

  • Execute human study for EB-iAC in Thailand and generate first clinical readouts to inform FDA-aligned endpoints.
  • Advance UAE programs toward conditional clinical use and complete build-out and validation of the Abu Dhabi GMP facility.
  • Progress EB-OC through early clinical implantation cohort and expand enrollment to support US discussions.
  • Book initial ex-US revenues through cost-recovery clinical use in the UAE, while preparing US reimbursement packages that leverage international outcomes.
  • Deepen UAE relationships with health system partners to support study starts and early clinical adoption, building on the Hub71 platform and regional visibility.

Market Opportunity

Market Dynamics

  • Orthopedic Regeneration and Grafts: The global bone grafts and substitutes market is estimated at $3.16B in 2024 and projected to reach $4.60B by 2030 at a 6.6% CAGR. Cartilage repair is a multi-billion dollar category as well, estimated at $5.98B in 2024 with growth to ~$8.0B by 2030. Cranio-maxillofacial devices add another $1.7B today with an expected ~9.5% CAGR through 2030.
  • Procedure Volume and Supply Constraints: ~2.2M orthopedic procedures worldwide involve bone grafting each year, with ~500K in the US alone. At the same time, supply of fresh osteochondral allografts in the US is only ~3K grafts per year, which severely caps access to biologic joint-sparing repair.
  • Musculoskeletal Disease Burden: 32.5M US adults live with osteoarthritis, a driver of joint repair and replacement demand. Globally, fragility fractures due to osteoporosis are enormous in scale, with recent estimates indicating tens of millions of fractures annually in people over 55.
  • International Commercial Beachhead Dynamics: The UAE combines large private health systems and robust medical tourism with 691K international health tourists visiting Dubai in 2023 and AED 1.03B in spend. PureHealth reports 100+ hospitals and 11K+ beds across its network. The UAE’s population is majority expatriate (commonly cited around 90%), supporting a mixed self-pay and insured market that is receptive to premium procedures.

Disease Burden Across Pipeline

  • Cranio-Maxillofacial (EB-CMF): Facial fractures and CMF defects remain common and morbid; a 2021 analysis estimated ~493K new facial fracture cases in the US in 2021, illustrating the scale of reconstructive need from trauma, congenital anomalies, and tumor resection.
  • Osteochondral Defects and Cartilage Repair (EB-OC): In the knee alone, 200-300K surgeries annually address symptomatic cartilage and osteochondral lesions, yet fresh OCA supply is limited to ~3K grafts per year in the US, leaving a large gap for durable biologic solutions.
  • Temporomandibular and Joint-Adjacent Cartilage (EB-iAC): Temporomandibular disorders affect 5-12% of the US population and are estimated to cost ~$4B annually to manage, underscoring demand for restorative approaches that go beyond palliative care.

Strategic Positioning
EpiBone’s platform grows living, patient-specific bone and cartilage from a person’s own adipose-derived stem cells, matured in custom perfusion bioreactors to match the exact anatomy captured by CT imaging. This approach aims to combine full anatomical fit with biologic integration and remodeling, a differentiated position relative to synthetics and cadaveric grafts.

In markets like knee cartilage repair, where procedure demand vastly exceeds allograft supply, and in CMF reconstruction, where precise form and function matter, EpiBone’s autologous, patient-matched grafts target clear pain points in access, fit, and long-term durability.

Three Major Inflection Points

  1. Ex-US Revenue Start in the UAE: The UAE launch pathway leverages Dubai’s medical-tourism demand and the PureHealth hospital network for clinical execution and early commercial adoption. The scale and cross-border patient flows in the UAE can accelerate time-to-revenue compared with a US-only path.
  2. Defense and High-Need Indications: The USAF Research Laboratory awarded EpiBone a purchase order in May 2025 to validate EB-CMF in craniofacial surgery, supporting adoption in demanding use cases and generating human experience that complements civilian indications.
  3. Regulatory Leverage of Foreign Data: Per company plans, international trials in the UAE and Thailand are being designed with FDA-aligned endpoints, with the intention to present foreign data in a future Type C meeting to inform US approval strategy and value inflection heading into the next institutional round.

Capitalization & Current Raise

EpiBone raised an $8M Seed round in December 2019 at a $27M pre-money valuation, led by Tech Council Ventures with participation from Amgen Ventures, Hackensack Meridian Health, and Henry Kravis. Capital supported IND clearance and first-in-human work for EB-CMF while scaling the perfusion bioreactor platform. In March 2024, the company introduced a $5M Pre-Series B bridge with a 30% discount to the Series B to begin ex-US expansion and advance EB-CMF, EB-OC, and EB-iAC toward next milestones. In November 2024, EpiBone closed a convertible note round led by Kendall Capital Partners with Lifespan Vision Ventures and EMV Capital to accelerate global clinical operations from Abu Dhabi.

In July 2025, EpiBone launched an insider-led Series A-1 Preferred of up to $4M equal to the prior Series A price, co-led by Kendall Capital Partners and Tech Council Ventures. The structure is pay-to-play with a 10 to 1 reverse split of existing preferred into common prior to the round and “pull-through” restoration for investors taking pro rata. A progressive Bonus Preferred schedule incentivizes investments above a certain level.

With $43M in equity financing and $3.9M in non-dilutive grants reported through early 2024, the company now adds additional non-dilutive support from a 2025 Air Force Research Laboratory award of about $1.25M to validate EB-CMF for maxillary use, strengthening the US defense revenue path.

Proceeds will:

  • Complete three EB-CMF implantations with the USAF.
  • Advance EB-OP to Phase II or III IND approval in the UAE and stand up a GMP facility in Abu Dhabi, including the Living Joint Replacement program.
  • Complete EB-iAC Phase I or II human implantations in Thailand and build the supply chain for off-the-shelf distribution.


The 2024 Kendall Capital-led note and the 2025 AFRL contract provide strategic, non-dilutive fuel that de-risks execution and creates a clear runway to a targeted Series B. The plan is milestone-driven: generate initial revenue in the UAE and the US defense channel, complete Thailand EB-iAC first-in-human, and advance through UAE and US regulatory gates. International studies are being built with FDA-aligned endpoints, with the intent to present the data in a late-2026 or early-2027 Type C meeting to shape and accelerate the US approval path.

Leadership Team

Pictured from left: Co-Founders Nina Tandon, PhD and Ik Bhumiratana, PhD

Dr. Nina Tandon, Co-Founder and CEO: Nina holds a PhD in biomedical engineering from Columbia, completed a postdoctoral fellowship in stem cells and tissue engineering at Columbia, and earned an Executive MBA in healthcare entrepreneurship from Columbia Business School. She is a TED Senior Fellow, a former McKinsey consultant, and an MIT alum in electrical engineering. Fast Company named her one of the 100 most creative people in business, and her TED talk on personalized medicine has surpassed 1M views.

Dr. Sarindr “Ik” Bhumiratana, Co-Founder and CSO: Trained at Columbia University for both his PhD and postdoctoral fellowship, Ik pioneered methods to engineer bone, cartilage, and osteochondral tissues from stem cells, work that underpins EpiBone’s platform. He is listed on two patents, has authored more than 15 peer-reviewed papers and four book chapters, and now leads translation of the science into clinical products and trials. Industry coverage credits his leadership in optimizing perfusion bioreactors to mimic in-vivo growth conditions for living grafts. 

Risks & Considerations

  • Regulatory Pathway and Reliance on Ex-US Data: The plan assumes conditional approvals in the UAE and Thailand, and that foreign clinical data with FDA-aligned endpoints will be persuasive in a future Type C meeting. Timelines, endpoint comparability, and agency acceptance are uncertain, which could extend time to US approval or require additional US trials and capital.
  • Manufacturing Scale-Up for Living Tissues: Standing up a GMP facility in Abu Dhabi and scaling perfusion bioreactors introduces risks in process transfer, batch consistency, release testing, sterility, and cold-chain logistics. Any delay in equipment validation, supply of critical raw materials, or meeting COGS targets can push out milestones and affect gross margins.
  • Clinical Adoption and Reimbursement: Surgeon adoption depends on clear superiority versus current standards such as allograft, synthetics, or MACI. Hospital value analysis committees will scrutinize cost, handling, and workflow. Broader coverage will require robust outcomes and health-economic evidence; coding and payment may lag early clinical use, pressuring pricing and ramp assumptions.
  • Financing Structure and Runway Sensitivity: The A-1 pay-to-play and reverse-split mechanics can reshape the cap table for non-participating holders, which may create governance or alignment challenges. The plan assumes a subsequent Series B on early outside-the-US and military revenues. If clinical or regulatory milestones slip, additional bridge capital or scope reductions may be required.
  • Geographic Execution and Partner Dependence: Success in the UAE and Thailand relies on local stakeholders for conditional approvals, sites, and in-kind support. Shifts in policy, partner priorities, or procurement cycles could impact trial starts, enrollment rates, or early commercial use. Cross-border operations add compliance, currency, and talent hiring risks.
  • Competition and IP Durability: Incumbent and emerging players across osteoporosis drugs, bone reconstruction, and cartilage repair continue to invest in next-gen products. EpiBone’s differentiation rests on autologous cells and patient-specific fabrication; challenges to freedom-to-operate, or competitors narrowing the gap on personalization or outcomes, could compress pricing power and share.

Potential Exit Scenarios

Upon discussion with the founders, EpiBone put together their view of how and where the company could exit. The following information is presented for illustrative purposes only and contains numerous assumptions made by EpiBone which may or may not occur. Investors should perform their own assessment, and are cautioned that milestones mentioned below may or may not be achieved.

Interested?