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Spine BioPharma

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uuid0000hme

Namestring
Spine BioPharma
Legal namestring
Spine BioPharma, Inc.
Websiteurl
spinebiopharma.com
Company typeenum
Private
Founded yearint
2015
Descriptiontext

Spine BioPharma's business model is that of a clinical-stage biotech: it generates no commercial revenue, monetizes value through equity and convertible debt financings rather than product sales, and intends to serve chronic low back pain patients with degenerative disc disease once (and if) SB-01 receives regulatory approval. The company has raised roughly $50 million in cumulative disclosed funding across multiple rounds since at least 2021, with named investors including Viscogliosi Brothers (lead investor in 2021), Cercano Management, Pacira Pharmaceuticals, and Vulcan Capital. Leadership is concentrated around Marc R. Viscogliosi as Chairman & CEO. Pricing, go-to-market, distribution, and reimbursement mechanics are not publicly disclosed because the company has no approved or commercialized product; near-term value creation depends on clinical re-strategy, partnership, or a pipeline expansion following the Phase III failure.

Short descriptiontext

Spine BioPharma is a privately held clinical-stage biopharmaceutical company developing SB-01, a TGFβ1-modulating peptide injection intended as a non-opioid, non-surgical treatment for chronic low back pain caused by degenerative disc disease.

Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
11–50
akta.pro rankint
HeadquartersNew York, United States
HQ citystring
New York
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Keyword5 values
peptide therapeutics, degenerative disc disease, non-opioid pain treatment, biopharmaceutical drug development, spinal disorder therapy
Industry2 codes
1Cartilage, Bone & Musculoskeletal Regeneration
CodeHLAAAGAHPrimaryYes
2Pain Management & Anesthesiology Pharmaceuticals
CodeHLAIAAANPrimaryNo
NAICS code2 codes
  • Pharmaceutical and Medicine Manufacturing3254
  • Research and Development in Biotechnology (except Nanobiotechnology)541714
SIC code1 code
  • Pharmaceutical Preparations2834
Product category
Biopharmaceutical peptide therapeutics for spinal disorders
Social media profiles1 record
Cost components4 values
Technology or R&D, Personnel, Operations, Others
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Core offering1 text field

Spine BioPharma develops SB-01 for injection, a peptide therapeutic designed to treat degenerative disc disease by modulating TGFβ1 to reduce inflammation and support disc health. The product is being advanced as a non-opiate, non-surgical treatment alternative for chronic low back pain associated with degenerative disc disease. The company's pipeline is centered on SB-01, which it has taken through Phase III clinical development (the MODEL trial).

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 value
  • Phase III MODEL trial did not meet primary endpoint for SB-01 in chronic low back pain
Product overview1 text field

Spine BioPharma is a biopharmaceutical company developing a single therapeutic candidate, SB-01 for injection. SB-01 is a peptide-based drug designed to treat degenerative disc disease by modulating TGFβ1 to reduce inflammation and support disc health, targeting chronic low back pain patients seeking non-opiate, non-surgical treatment options. The company's primary pipeline activity is advancing SB-01 through clinical development, having completed a Phase III MODEL trial.

Product and service1 record
1SB-01 for injection
CategoryPeptide therapeutic (investigational drug)
Description

SB-01 for injection is a peptide therapeutic designed to treat degenerative disc disease by modulating TGFβ1 to reduce inflammation and support disc health. It is being developed as a non-opiate, non-surgical treatment for chronic low back pain associated with degenerative disc disease, targeting patients who would otherwise rely on opioids or surgical interventions.

Scale indicator5 records

Each record includes

Type, Value, Description, Source

Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight3 records

Each record includes

Type, Description

Peers10 records
1Kolon TissueGene
TypeDirect peer
Description

Develops TG-C, an allogeneic cell-based therapy for degenerative disc disease that has advanced through late-stage clinical trials — a direct competitor in the same indication using a related regenerative approach.

2Pacira BioSciences
TypeBroad incumbent
Description

Specialty pharmaceutical company commercializing non-opioid pain therapeutics (e.g., EXPAREL) and a strategic investor in Spine BioPharma. Comparable as a broad incumbent in non-opioid pain and as a strategic stakeholder in the asset.

3Mesoblast
TypeDirect peer
Description

Commercial-stage cellular medicines company that has run late-stage clinical trials of MPC-06-ID for chronic low back pain due to degenerative disc disease — directly competitive in indication, mechanism class, and clinical stage.

4DiscGenics
TypeDirect peer
Description

Clinical-stage regenerative medicine company developing IDCT (rebonupatamagene autotemcel), a cell therapy for degenerative disc disease — the most directly comparable asset and indication to SB-01.

5BioRestorative Therapies
TypeEmerging player
Description

Early-stage stem cell therapy developer with programs targeting disc and spine-related conditions; partial overlap in mechanism and indication with SB-01.

6Seikagaku Corporation
TypeDirect peer
Description

Japanese specialty pharma with marketed joint-preservation products (hyaluronic acid, disc-related injectables) and pipeline assets in MSK regeneration — overlapping with SB-01's MSK/peptide therapeutic space.

7Anika Therapeutics
TypeDirect peer
Description

Joint-preservation and regenerative medicine company with hyaluronic-acid-based therapies for osteoarthritis and adjacent MSK indications — overlapping therapeutic category and commercial channels.

8Scilex Holding
TypeBroad incumbent
Description

Commercial-stage non-opioid pain management company controlled by the Viscogliosi Brothers. Compares as a related-party incumbent in the same non-opioid pain therapeutic space and through overlapping leadership/ownership.

9Sorrento Therapeutics
TypeBroad incumbent
Description

Diversified biopharma with pain management assets (including non-opioid injectables) — broader incumbent operating in the same pain therapeutics category that SB-01 targets.

10VIVEX Biologics
TypeDirect peer
Description

Specialty spine and orthopedics biologics company marketing amniotic membrane and tissue-based products for spine surgery and disc-related applications — comparable in spine therapeutic focus.

Market position
Strengths4 records

Each record includes

Headline, Details, Source

Weaknesses4 records

Each record includes

Headline, Details, Source

Competitive moat3 records

Each record includes

Type, Details

Key risks6 records

Each record includes

Headline, Details, Source

Key highlights5 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Segment1 record

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile1 record

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
Yes
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature1 record

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles1 record

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds12 records

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors4 records

Each record includes

Name, Type, Date of entry, Rounds participated, Website

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

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

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

Spine BioPharma

Biopharmaceutical peptide therapeutics for spinal disordersspinebiopharma.com

Spine BioPharma is a privately held clinical-stage biopharmaceutical company developing SB-01, a TGFβ1-modulating peptide injection intended as a non-opioid, non-surgical treatment for chronic low back pain caused by degenerative disc disease.

What Spine BioPharma does

Spine BioPharma's business model is that of a clinical-stage biotech: it generates no commercial revenue, monetizes value through equity and convertible debt financings rather than product sales, and intends to serve chronic low back pain patients with degenerative disc disease once (and if) SB-01 receives regulatory approval. The company has raised roughly $50 million in cumulative disclosed funding across multiple rounds since at least 2021, with named investors including Viscogliosi Brothers (lead investor in 2021), Cercano Management, Pacira Pharmaceuticals, and Vulcan Capital. Leadership is concentrated around Marc R. Viscogliosi as Chairman & CEO. Pricing, go-to-market, distribution, and reimbursement mechanics are not publicly disclosed because the company has no approved or commercialized product; near-term value creation depends on clinical re-strategy, partnership, or a pipeline expansion following the Phase III failure.

Spine BioPharma firmographics

Firmographics
Name
Spine BioPharma
Legal name
Spine BioPharma, Inc.
Website
https://spinebiopharma.com
Company type
Private
Founded year
2015
Operating status
Operating
Headcount range
11–50 employees
Short description
Spine BioPharma is a privately held clinical-stage biopharmaceutical company developing SB-01, a TGFβ1-modulating peptide injection intended as a non-opioid, non-surgical treatment for chronic low back pain caused by degenerative disc disease.
Ownership category
akta.pro rank

Spine BioPharma industry classification

Industry
Product category
Biopharmaceutical peptide therapeutics for spinal disorders
NAICS
Pharmaceutical and Medicine Manufacturing (3254), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
SIC
Pharmaceutical Preparations (2834)
akta.pro primary industry
Cartilage, Bone & Musculoskeletal Regeneration (HLAAAGAH)
akta.pro secondary industry
Pain Management & Anesthesiology Pharmaceuticals (HLAIAAAN)

Keywords

  • Peptide therapeutics
  • Degenerative disc disease
  • Non-opioid pain treatment
  • Biopharmaceutical drug development
  • Spinal disorder therapy

Where Spine BioPharma is headquartered

Location

Headquarters

HQ city
New York
HQ country
United States
HQ region
North America

Markets served

Spine BioPharma business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Technology or R&D, Personnel, Operations, Others

Spine BioPharma product offering

Product offering

Core offering

Spine BioPharma develops SB-01 for injection, a peptide therapeutic designed to treat degenerative disc disease by modulating TGFβ1 to reduce inflammation and support disc health. The product is being advanced as a non-opiate, non-surgical treatment alternative for chronic low back pain associated with degenerative disc disease. The company's pipeline is centered on SB-01, which it has taken through Phase III clinical development (the MODEL trial).

Product overview

Spine BioPharma is a biopharmaceutical company developing a single therapeutic candidate, SB-01 for injection. SB-01 is a peptide-based drug designed to treat degenerative disc disease by modulating TGFβ1 to reduce inflammation and support disc health, targeting chronic low back pain patients seeking non-opiate, non-surgical treatment options. The company's primary pipeline activity is advancing SB-01 through clinical development, having completed a Phase III MODEL trial.

Differentiator

Problem solved

Functional benefit

Products and services

  • SB-01 for injection SB-01 for injection is a peptide therapeutic designed to treat degenerative disc disease by modulating TGFβ1 to reduce inflammation and support disc health. It is being developed as a non-opiate, non-surgical treatment for chronic low back pain associated with degenerative disc disease, targeting patients who would otherwise rely on opioids or surgical interventions.

Quantifiable outcome

  • Phase III MODEL trial did not meet primary endpoint for SB-01 in chronic low back pain

Companies that use Spine BioPharma

Customer profile

Segments1 record

Ideal customer profiles1 record

Spine BioPharma technology and API

Technology

Technology focussed Yes

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature1 record

Spine BioPharma partnerships and signals

Strategic signal

Scale indicators5 records

Recent moves6 records

Expansion highlights3 records

Spine BioPharma competitors and assessment

Company assessment

Direct peers

  • Kolon TissueGene: Develops TG-C, an allogeneic cell-based therapy for degenerative disc disease that has advanced through late-stage clinical trials — a direct competitor in the same indication using a related regenerative approach.
  • Mesoblast: Commercial-stage cellular medicines company that has run late-stage clinical trials of MPC-06-ID for chronic low back pain due to degenerative disc disease — directly competitive in indication, mechanism class, and clinical stage.
  • DiscGenics: Clinical-stage regenerative medicine company developing IDCT (rebonupatamagene autotemcel), a cell therapy for degenerative disc disease — the most directly comparable asset and indication to SB-01.
  • Seikagaku Corporation: Japanese specialty pharma with marketed joint-preservation products (hyaluronic acid, disc-related injectables) and pipeline assets in MSK regeneration — overlapping with SB-01's MSK/peptide therapeutic space.
  • Anika Therapeutics: Joint-preservation and regenerative medicine company with hyaluronic-acid-based therapies for osteoarthritis and adjacent MSK indications — overlapping therapeutic category and commercial channels.
  • VIVEX Biologics: Specialty spine and orthopedics biologics company marketing amniotic membrane and tissue-based products for spine surgery and disc-related applications — comparable in spine therapeutic focus.

Broad incumbents

  • Pacira BioSciences: Specialty pharmaceutical company commercializing non-opioid pain therapeutics (e.g., EXPAREL) and a strategic investor in Spine BioPharma. Comparable as a broad incumbent in non-opioid pain and as a strategic stakeholder in the asset.
  • Scilex Holding: Commercial-stage non-opioid pain management company controlled by the Viscogliosi Brothers. Compares as a related-party incumbent in the same non-opioid pain therapeutic space and through overlapping leadership/ownership.
  • Sorrento Therapeutics: Diversified biopharma with pain management assets (including non-opioid injectables) — broader incumbent operating in the same pain therapeutics category that SB-01 targets.

Emerging players

  • BioRestorative Therapies: Early-stage stem cell therapy developer with programs targeting disc and spine-related conditions; partial overlap in mechanism and indication with SB-01.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights5 records

Customer concentration

Spine BioPharma social profiles

Digital presence

Spine BioPharma financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Spine BioPharma leadership team

Management profile

Number of profiles

Profiles1 record

Spine BioPharma funding detail

Funding detail

Funding overview

Funding rounds12 records

Investors4 records

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

Spine BioPharma M&A and investment

M&A and investment

M&A

Investments

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

Frequently asked questions about Spine BioPharma

What does Spine BioPharma do?

Spine BioPharma develops SB-01 for injection, a peptide therapeutic designed to treat degenerative disc disease by modulating TGFβ1 to reduce inflammation and support disc health. The product is being advanced as a non-opiate, non-surgical treatment alternative for chronic low back pain associated with degenerative disc disease. The company's pipeline is centered on SB-01, which it has taken through Phase III clinical development (the MODEL trial).

Is Spine BioPharma a public or private company?

Spine BioPharma is a private company. It is classified as venture growth investor backed and is currently operating.

When was Spine BioPharma founded?

Spine BioPharma was founded in 2015. It employs 11 to 50 people.

Where is Spine BioPharma based?

Spine BioPharma is headquartered in New York, United States, in the North America region.

Who are Spine BioPharma's main competitors?

Direct peers on record are Kolon TissueGene, Mesoblast, DiscGenics, Seikagaku Corporation, Anika Therapeutics and VIVEX Biologics. Broad incumbents are Pacira BioSciences, Scilex Holding and Sorrento Therapeutics. BioRestorative Therapies is listed as an emerging player.

Does Spine BioPharma have an API?

No public API is recorded for Spine BioPharma.

What industry is Spine BioPharma in?

Spine BioPharma's product category is Biopharmaceutical peptide therapeutics for spinal disorders. Its primary akta.pro industry code is HLAAAGAH, Cartilage, Bone & Musculoskeletal Regeneration, with a secondary code of HLAIAAAN, Pain Management & Anesthesiology Pharmaceuticals. Its NAICS code is 3254 and its SIC code is 2834.

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Live signals
The Pharma LetterSpine BioPharma Phase III MODEL Trial For SB-01 missSpine BioPharma announced that its Phase III MODEL trial for SB-01, a treatment for chronic low back pain related to degenerative disc disease, failed to meet its primary endpoints six months post-treatment. The trial aimed to evaluate the effectiveness of the TGF-β antagonist in improving pain intensity and function but showed no significant improvement compared to a sham control. This outcome may impact the company's future strategies in this therapeutic area.AijournDegenerative Disc Disease Market to Observe Stupendous Growth at ~19% CAGR by 2036, Due to Launch of Novel Drug Classes Such as Cell Replacement, NF-kappa B Inhibitors, Cartilage Regeneration via TGF-DelveInsight published a market research report projecting the degenerative disc disease market to grow from USD 1.2 billion in 2025 at a ~19% CAGR, reaching substantial size by 2036, with the United States representing approximately 75% of the 7MM market. Multiple companies are actively advancing regenerative therapies including SB-01 (Spine Biopharma), IDCT (DiscGenics), rexlemestrocel-L (Mesoblast and Grünenthal), BRTX-100 (BioRestorative Therapies), and others through various clinical trial phases, shifting treatment from symptom-focused approaches toward disease-modifying therapies. Recent developments include Phase III trial launches, positive topline results, regulatory designation awards, and strategic partnerships aimed at accelerating commercialization of these pipeline candidates.PR NewswireDegenerative Disc Disease Market to Observe Stupendous Growth at ~19% CAGR by 2036, Due to Launch of Novel Drug Classes Such as Cell Replacement, NF-kappa B Inhibitors, Cartilage Regeneration via TGF-DelveInsight has published a market research report projecting the degenerative disc disease (DDD) treatment market to grow at approximately 19% CAGR, reaching an estimated USD 1.2 billion across the 7MM (United States, EU4, United Kingdom, and Japan) in 2025. The United States represents the largest market segment, accounting for approximately 75% of total market size in 2025, with nearly 28 million diagnosed prevalent cases across the 7MM. The report highlights a shift toward regenerative and disease-modifying therapies, including cell-based treatments such as SB-01 (Spine Biopharma), IDCT (DiscGenics), rexlemestrocel-L (Mesoblast and Grünenthal), BRTX-100 (BioRestorative Therapies), and AMG0103 (AnGes), which are advancing through clinical development for DDD treatment.The Manila TimesChronic and Acute Pain Clinical Trial Pipeline Analysis: 150+ Key Companies Shaping the Future of Chronic and Acute Pain TherapeuticsDelveInsight published a comprehensive pipeline report covering 150+ companies developing 200+ chronic and acute pain drugs across various clinical stages, with approximately 30 drugs in mid-stage and 50+ in early-stage development. Key recent developments include Vertanical submitting VER-01 for marketing authorization in European countries following positive Phase III results, while several companies reported regulatory milestones, trial completions, and licensing collaborations in the pain therapeutics space. The report highlights a shift toward non-opioid, targeted therapies driven by concerns around opioid dependence, though Spine BioPharma announced its Phase III MODEL trial did not meet its primary endpoint for SB-01 in chronic low back pain.Clinical Trials ArenaSpine BioPharma’s trial of SB-01 fails to meet primary endpointSpine BioPharma's Phase III MODEL trial for its TGF-β antagonist therapy SB-01 failed to meet its primary endpoint regarding pain intensity and function in patients with degenerative disc disease. Although the treatment group showed numerical improvements, the results did not reach statistical significance compared to the sham control. The company plans to conclude data analysis and engage with the FDA to discuss potential approval pathways.FierceBiotechSpine BioPharma misses primary endpoint in back pain phase 3, blames sham response rateSpine BioPharma's phase 3 trial for its chronic low back pain candidate SB-01 missed its primary endpoint, a failure the company attributes to an unexpectedly high response rate in the sham control group. The biotech plans to meet with the FDA to discuss potential pathways for market approval despite the statistical setback.Business Wire BlogSpine BioPharma Announces Topline Results from Phase 3 MODEL Trial For SB-01 (vicatertide) In Chronic Low Back Pain Associated with Degenerative Disc DiseaseSpine BioPharma announced that its Phase 3 MODEL trial for SB-01 (vicatertide) failed to meet its primary endpoint for treating chronic low back pain associated with degenerative disc disease, primarily due to a higher-than-anticipated response rate in the sham control group. Despite missing statistical significance, the drug demonstrated a robust safety profile and clinically meaningful improvements in pain intensity and function compared to baseline. The company plans to review the data and consult with the FDA regarding potential approval pathways.SecSEC FORM DSpine BioPharma, Inc. filed a Form D with the Securities and Exchange Commission to report an exempt offering of convertible notes under Rule 506(b). The company has raised $13,505,000 out of a total offering amount of $23,500,000 USD from ten investors as of the filing date.Clinical Trials ArenaSpine BioPharma concludes enrolment in Phase III back pain treatment trialSpine BioPharma has concluded subject enrolment in its Phase III MODEL clinical trial for SB-01, a treatment for chronic lower back pain caused by degenerative disc disease. The trial enrolled 417 subjects across 30 sites in the US over two years to evaluate the safety and efficacy of the synthetic peptide. This milestone brings the drug closer to potential market entry for patients who currently lack non-surgical alternatives.PR NewswireSpine BioPharma, Inc. Announces Agreement with Ensol BioSciences, Inc. to Expand Indications for SB-01 For InjectionSpine BioPharma, Inc. has signed an agreement with Ensol BioSciences, Inc. to expand the indications of its therapeutic drug candidate, SB-01 For Injection, to include conditions like osteoarthritis and fibrotic diseases. The agreement is valued at $155 million and gives Spine BioPharma exclusive rights for further development and commercialization of the drug. The company is also conducting a Phase 3 study for SB-01, which it expects to complete enrollment in September 2024.