TheraNova LLC.

What TheraNova LLC. does

TheraNova LLC is a privately held medical device venture studio and incubator founded in 2006 by Dr. Dan Burnett and headquartered at 255 Kansas Street in San Francisco. The company operates a capital-efficient shared R&D model that takes medical devices from concept through clinical trials, FDA regulation, reimbursement, and commercialization. Since inception, TheraNova has spun out 20 portfolio companies spanning diverse therapeutic areas — including Accuryn (monitoring), Cerene (women's health), CardioSpire (cardiovascular), Bone Health Technologies, SoleStim, Sequana, Gravitas, Centese, and others — and has accumulated 12 FDA regulatory clearances (PMA and 510K), 120+ granted US patents, and 30+ completed clinical trials.

The company's underlying technology platform integrates engineering (mechanical, electrical, manufacturing, software, electro-mechanical), rapid prototyping (3D printing, machining, experimental test design, silicone molding), and regulatory/quality management capabilities. TheraNova supplements this with reimbursement consulting partnerships and clinical research conducted across the United States, Europe, and South America. The leadership team combines clinical, IP, and regulatory depth: CEO Dan Burnett (MD/MBA from Duke, inventor on 57 issued US patents), CMO Shane Mangrum (board-certified physiatrist), and CSO Eran Steinberg (300+ issued patents, five prior exits, USPTO patent agent).

TheraNova's revenue mechanics are those of a venture studio rather than a product company: cumulative non-dilutive government grants exceed $35M, and the studio has helped raise more than $400M to its portfolio companies (with Dr. Burnett directly involved in raising over $250M across 14 spinouts). The company's go-to-market is its spinout pipeline — incubated programs are supported by a mix of internal capital, grants, and angel funding, with prospective investors and partners reached primarily via direct email ([email protected]) and the company's professional network. Pricing for any studio services is not publicly disclosed.

Name

TheraNova LLC.

Legal name

TheraNova LLC

Website

https://theranova.com

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

11–50 employees

Short description

TheraNova LLC is a San Francisco-based medical device venture studio founded in 2006 that develops devices from concept through FDA approval, having spun out 20 companies with 12 FDA clearances and helped raise $400M+ to its portfolio.

Ownership category

akta.pro rank

Product category

Medical Device Development Services

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Clinical Site Start-Up & Activation (Regulatory/Ethics/Contracts) (HLAGACAC)

akta.pro secondary industries

Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE), Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH)

Keywords

• Medical device development
• Venture studio incubator
• Medical device commercialization
• FDA regulatory navigation
• Clinical trial execution

Headquarters

HQ city

San Francisco

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Infrastructure, Marketing or Sales

Marketing channels1 record

Core offering

TheraNova is a medical device venture studio and incubator that develops medical devices from concept through clinical trials, regulation, reimbursement, and commercialization using a capital-efficient shared R&D model. Since inception it has spun out 20 companies, raised over $400M for its portfolio companies, secured 12 FDA regulatory clearances, and filed more than 120 US patents.

Product overview

TheraNova is a venture-studio and incubator specializing in medical device development, taking products from concept through clinical trials, regulation, and commercialization. The company operates a shared R&D model and has spun out 20 companies including Accuryn, Cerene, Perikinetics, Alsus, Emblem, Piccolo, Ananya, Empower, Sequana, Bone Health Technologies, EM Kinetics, SoleStim, CardioSpire, Gravitas, Centese, and Just Air. TheraNova also maintains a portfolio of incubated companies supported by internal capital, grant, and angel funding. The company's capabilities span engineering (mechanical, electrical, manufacturing, software, electro-mechanical), rapid prototyping (3D printing, machining, experimental test design, silicone molding), and management services (quality system implementation, clinical study execution, FDA guideline compliance).

Differentiator

Problem solved

Functional benefit

Brands

• TheraNova: Medical device venture-studio and incubator brand

Products and services

• TheraNova Venture Studio and Incubator Services End-to-end medical device development services including engineering (mechanical, electrical, manufacturing, software, electro-mechanical), rapid prototyping (3D printing, machining, experimental test design, silicone molding), and management services such as quality system implementation, clinical study execution, and FDA guideline compliance. Services are delivered through a shared R&D model that has produced 20 spinout companies.

Quantifiable outcome

• 12 FDA regulatory clearances achieved (PMA and 510K)
• +2 more outcomes

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators6 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• JLABS (Johnson & Johnson Innovation): JLABS is J&J's no-strings-attached medical device and biotech incubator network providing lab space, regulatory, and commercialization support to early-stage companies. It is broader in scope and backed by a strategic acquirer, but addresses the same unmet need of capital-efficient early-stage medical device development.
• MedTech Innovator: MedTech Innovator is the largest medical device accelerator globally, running a portfolio of startups through a structured program with mentorship, hospital pilots, and investor introductions. While broader and accelerator-based rather than a full venture studio, it competes for the same early-stage medical device founders and capital.
• Cleveland Clinic Innovations: Cleveland Clinic Innovations is the commercialization arm of Cleveland Clinic, spinning out medical device and digital health companies from clinician-led inventions. It operates a similar shared R&D model but with an academic medical center anchor providing hospital access and clinician deal flow.
• Stryker (innovation / venture arm): Stryker is a global medical device incumbent that operates corporate venture and business development programs to source and acquire early-stage device innovations. It is a likely acquirer profile for TheraNova spinouts and represents the strategic exit path the studio targets.

Direct peers

• Fogarty Innovation: Fogarty Innovation is a medical device incubator based at El Camino Hospital in Mountain View, CA. It operates a similar model — supporting physician-innovators through prototyping, clinical translation, and spinout formation — making it the closest geographic and functional peer to TheraNova.
• Coridea: Coridea is a medical device incubator founded by serial medtech entrepreneur Howard Levin. It operates on a similar shared R&D model, taking concepts from invention through FDA approval and spinout, with notable exits including CardioMEMS (acquired by St. Jude Medical).
• MD Start: MD Start is a European medical device incubator that funds and develops very early-stage inventions through to clinical proof-of-concept. It shares TheraNova's model of forming dedicated companies around individual device concepts and bringing them to first-in-human trials.

Emerging players

• NXT Biomedical: NXT Biomedical is a medical device incubator focused on interventional cardiology and structural heart devices. It operates with a similar venture-studio framework of developing multiple device concepts in parallel with shared infrastructure.

Regional players

• Mount Sinai Innovation Partners: Mount Sinai Innovation Partners commercializes medical inventions emerging from the Mount Sinai Health System, spinning out device, diagnostic, and digital health companies. It is comparable to TheraNova in transitioning clinical innovations into standalone companies but is anchored to a single academic system.

Others

• Westlake Village BioPartners: Westlake Village BioPartners is a venture capital firm focused on early-stage biotech and medical device companies. While not an incubator itself, it is a frequent co-investor alongside studios like TheraNova and serves as a comparable capital partner in the medical device spinout ecosystem.

Market position

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Customer concentration

• LinkedInlinkedin.com/company/theranova-llc

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds2 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about TheraNova LLC.