Serene

What Serene does

Serene, LLC is a privately-held clinical-stage radiopharmaceutical company founded in 2014 (originally as R-NAV, LLC, renamed in September 2016) and headquartered in The Woodlands, Texas. The company is built on a first-in-class tin-117m (Sn-117m) isotope platform that emits therapeutic conversion electrons with short tissue penetration (~300 micrometers) and imagable photons, enabling simultaneous therapy and imaging (theranostics). Sn-117m's approximately two-week half-life supports practical shipping and handling, and no other medical isotope has been identified with the same combination of properties.

Serene's product portfolio spans veterinary and human health. Its lead commercial product, Synovetin OA — a homogeneous Sn-117m colloid for radiosynoviorthesis treatment of canine osteoarthritis — is commercialized through spin-off Exubrion Therapeutics, with distribution via AmerisourceBergen subsidiaries MWI Animal Health and Securos Surgical. The human pipeline includes Sn-117m-DTPA for bone metastases (NIH-sponsored Phase 2 active, FDA IND approved October 2021), tin-117m homogeneous microparticles (Synovacoll) for human radiosynoviorthesis (Phase 1b in Canada), Sn-117m-DOTA-annexin V for vulnerable atherosclerotic plaque (Phase 1/2 in carotid artery stenosis), Sn-117m-electroplated biliary stents, Sn-117m microparticles for unresectable hepatocellular carcinoma, and suprachoroidal Sn-117m microparticles for age-related macular degeneration.

Serene's business model combines (i) veterinary product sales through Exubrion via distribution partnerships, (ii) licensing and co-development arrangements with pharmaceutical and academic partners (notably a CRADA with the NCI NExT program and a Department of Energy isotope production agreement), and (iii) future human-health revenue contingent on regulatory approvals. The company maintains cGMP manufacturing at Theragenics Corporation and other U.S. sites, holds multiple Sn-117m patents, and has an extensive scientific publication record (over 80 papers). Headcount is 11-50, and no public revenue is disclosed.

Name

Serene

Legal name

Serene, LLC

Website

https://serene-llc.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Serene is a privately-held radiopharmaceutical company developing a first-in-class tin-117m isotope platform for theranostic applications in oncology, rheumatology, cardiovascular disease, and ophthalmology, with a commercial veterinary product (Synovetin OA) sold via its Exubrion Therapeutics spin-off and a clinical-stage human pipeline.

Ownership category

akta.pro rank

Product category

Radiopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Therapeutic Radiopharmaceuticals (Radioligand/Targeted Radionuclide Therapy) (HLAIAGAB)

akta.pro secondary industries

Theranostic Radiopharmaceutical Platforms (Paired Dx/Tx) (HLAIAGAC), Diagnostic Radiopharmaceuticals (SPECT/PET Tracers) (HLAIAGAA), Rare Ophthalmology Disorder Therapies (HLAIAIAK)

Keywords

• Radiopharmaceutical development
• Tin-117m isotopes
• Veterinary radiopharmaceuticals
• Bone metastases therapy
• Radiosynoviorthesis treatment

Headquarters

HQ city

The Woodlands

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Veterinary radiopharmaceutical products: Serene's spin-off Exubrion Therapeutics commercializes Synovetin OA, a tin-117m colloid for canine osteoarthritis, distributed through MWI Animal Health and Securos Surgical (AmerisourceBergen). This represents the company's first commercially available product.
2. Human health radiopharmaceutical products: Pipeline of tin-117m-based products for human use including Sn-117m-DTPA for bone metastases, Sn-117m microparticles for radiosynoviorthesis (Synovacoll), and Sn-117m-DOTA-annexin V for vulnerable plaque. Revenue anticipated upon regulatory approvals through clinical development partnerships with NCI and institutional trial sites.
3. Licensing and co-development partnerships: Serene licenses its technology and partners with pharmaceutical companies, medical device manufacturers, and research institutions. Development agreements include NCI CRADA, Department of Energy isotope production contracts, and co-development with academic medical centers.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels6 records

Core offering

Serene develops and commercializes radiopharmaceuticals based on its proprietary tin-117m (Sn-117m) isotope platform, which emits therapeutic conversion electrons and imagable photons for theranostic applications. The company sells Synovetin OA (a homogeneous Sn-117m colloid for canine osteoarthritis) commercially through its spin-off Exubrion Therapeutics, and is advancing a pipeline of human-health products for bone metastases, human radiosynoviorthesis, vulnerable atherosclerotic plaque, hepatic cancer, biliary cancer, and age-related macular degeneration.

Product overview

Serene is a radiopharmaceutical company built on a first-in-class tin-117m isotope platform technology. The company develops multiple products based on tin-117m conversion electron emissions for cancer, rheumatology, and cardiovascular applications. Key products include Synovetin OA (veterinary canine osteoarthritis treatment commercialized through spinoff Exubrion Therapeutics), tin-117m-DTPA (bone metastases treatment in Phase 2 trials), tin-117m homogeneous microparticles/Synovacoll (human radiosynoviorthesis in Phase 1B), tin-117m-DOTA-annexin V (vulnerable plaque imaging/therapy), tin-117m electroplated stents (biliary obstruction), tin-117m microparticles for hepatic cancer, and tin-117m microparticles for age-related macular degeneration. The company operates through development partnerships and cGMP manufacturing sites in the United States.

Differentiator

Problem solved

Functional benefit

Brands

• Synovetin OA: Proprietary tin-117m colloid formulation for treatment of canine osteoarthritis using radiosynoviorthesis, commercialized through spin-off company Exubrion Therapeutics.
• Synovacoll

Products and services

• Synovetin OA A proprietary homogeneous Sn-117m colloid for radiosynoviorthesis treatment of canine osteoarthritis. Marketed by Exubrion Therapeutics, Serene's spin-off, with distribution through MWI Animal Health and Securos Surgical (AmerisourceBergen). Demonstrated pain relief in 92% of dogs with mild or moderate elbow osteoarthritis, with effects lasting up to a year from a single treatment.
• Tin-117m-DTPA A bone-binding radiopharmaceutical for treatment of painful bone metastases from prostate and breast cancer. High specific activity formulation with approximately four-week shelf life; rapidly and irreversibly binds to bone with increased binding in areas of increased bone turnover, with remainder rapidly excreted in urine. In Phase 2 NIH-sponsored trial at University of Kentucky.
• Synovacoll (Tin-117m Homogeneous Microparticles) A homogeneous Sn-117m microparticle formulation for radiosynoviorthesis in humans, used for treatment of refractory rheumatoid arthritis, osteoarthritis and other arthritides. Authorized by Health Canada for Phase 1B trial.
• Tin-117m-DOTA-annexin V A targeted radiopharmaceutical in which annexin V conjugated to tin-117m binds phosphatidylserine exposed on apoptotic cells in atherosclerotic plaque, enabling simultaneous imaging and therapeutic targeting of vulnerable plaque. Phase 1/2 human trial completed for inoperable high-grade carotid artery stenosis.
• Tin-117m Electroplated Biliary Stent A medical device consisting of tin-117m electroplated onto stainless steel stents, designed to anchor in place and deliver targeted radiotherapy for treatment of malignant biliary tract obstruction.
• Tin-117m Microparticles for Hepatic Cancer Tin-117m microparticles delivered via catheter through the hepatic artery to treat unresectable hepatocellular carcinoma (HCC). Emits therapeutic conversion electrons, unlike existing Y-90 beta-emitting isotopes.
• Tin-117m Microparticles for Age-Related Macular Degeneration Tin-117m microparticles deployed suprachoroidally for treatment of various forms and stages of age-related macular degeneration (AMD), targeting neovascular and inflammatory components.

Quantifiable outcome

• Three-quarters of bone metastases patients experienced major to complete relief of bone pain at doses well below maximum tolerated dose, with mean onset of pain relief less than a week and mean duration greater than three months
• +3 more outcomes

Named customers5 records

Segments6 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Nine partnerships are on record, tiered core.

• National Cancer Institute (NCI) — NExT ProgramcoreStrategic or Co-development Partner · 13 December 2019Serene entered into a cooperative research and development agreement (CRADA) with NCI through the NExT program. NCI funds and manages clinical trials, data analysis, and regulatory development for Sn-117m-DTPA. Serene supplies tin-117m-DTPA to NCI-selected investigators.
• MWI Animal HealthcoreChannel Partner/ Reseller/ Distributor · 26 September 2017MWI Animal Health, part of AmerisourceBergen, made an investment in Serene and negotiated a distribution partnership with Serene's veterinary subsidiary Convetra Inc. MWI serves as a primary distributor for Synovetin OA to veterinary practices across the US.
• Securos SurgicalcoreChannel Partner/ Reseller/ Distributor · 26 September 2017Securos Surgical, part of AmerisourceBergen, invested in Serene and entered into a distribution partnership with Convetra Inc for Synovetin OA and other veterinary tin-117m products.
• Department of EnergycoreStrategic or Co-development PartnerThe Department of Energy entered into an agreement with Serene to produce high specific activity (HSA) Sn-117m for pre-clinical development through 2Q 2023 and throughout the FDA Phase 2 NIH-sponsored clinical trial of bone metastases. This ensures reliable isotope supply.
• Isotherapeutics GroupcoreStrategic or Co-development PartnerIsotherapeutics Group is an experienced radiopharmaceutical development company contracted by Serene for development of improved high specific activity tin-117m-DTPA product. Has worked on numerous previous Serene projects.
• Exubrion TherapeuticscoreOEM/ Whitelabel/ Licensing PartnerExubrion Therapeutics is a spin-off company from Serene that commercializes Synovetin OA (tin-117m colloid for canine osteoarthritis). Serene co-founders Gilbert Gonzales and Nigel Stevenson hold leadership roles at Exubrion.
• Convetra InccoreOEM/ Whitelabel/ Licensing PartnerConvetra Inc is Serene's veterinary subsidiary focused on utilizing tin-117m formulations for unmet needs in the veterinary space. It is currently conducting clinical trials in canine osteoarthritis and has a distribution partnership with MWI and Securos.
• Theragenics CorporationcoreTechnology or IntegrationTheragenics Corporation hosts Serene's commercial manufacturing facility at its site, completing processes and procedures to supply Synovetin OA. Validations were conducted to support all future trials and commercial demands.
• Brookhaven National LaboratorycoreStrategic or Co-development PartnerSerene built on pioneering work initiated at Brookhaven National Laboratory for tin-117m radiopharmaceutical development. Original development of tin-117m as a bone-binding radiopharmaceutical was led by Suresh Srivastava and colleagues at Brookhaven.

Scale indicators8 records

Recent moves7 records

Expansion highlights5 records

Market position

Competitive moat5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/serene-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Subsidiaries2 records

Funding overview

Funding rounds

Investors

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 Serene