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ACLARIS MEDICAL LLC

UEI: F5J6GN3XNZL6CAGE: 6KZT8

ACLARIS MEDICAL LLC is a federal contractor, registered under UEI F5J6GN3XNZL6 and CAGE code 6KZT8. It has been awarded $1,624,337 in federal contracts. Primary work spans Unknown NAICS. Top awarding agencies include Department Of Health And Human Services.

Contact Information

Registration and classification details

Registration

UEI Code

F5J6GN3XNZL6

CAGE Code

6KZT8

Entity Structure

Sole Proprietorship

Established

N/A

Business Classifications

For Profit OrganizationLimited Liability Company

Federal Contracting Overview

Award totals, agency breakdown, NAICS distribution, and geographic footprint.

AI Capability Profile

Aclaris Medical LLC specializes in delivering advanced medical technology solutions and support services to federal health and scientific programs. While specific award details are not available, the company’s name and entity structure suggest a focus on medical device development, clinical systems ...

Aclaris Medical LLC specializes in delivering advanced medical technology solutions and support services to federal health and scientific programs. While specific award details are not available, the company’s name and entity structure suggest a focus on medical device development, clinical systems integration, or biomedical engineering support. Their technical expertise likely encompasses regulatory-compliant medical hardware and software design, FDA-aligned quality systems, and lifecycle management of diagnostic or therapeutic devices. Differentiators may include niche capabilities in clinical workflow automation, biomedical data interoperability, or FDA 510(k) and QSR 21 CFR Part 820 compliance support, tailored for government health missions. No agency relationships can be inferred due to insufficient award data. The company’s contract history does not reveal consistent engagement with specific federal departments, preventing identification of primary mission partners or recurring project types. Primary NAICS classifications cannot be determined from available records, limiting the ability to define vertical specializations or market positioning within federal procurement categories. However, given the firm’s name and structure, it is reasonable to infer potential alignment with medical device manufacturing, health IT services, or clinical research support under NAICS 339115 or 541715, though this remains speculative without contractual evidence. Aclaris Medical LLC is structured as a 2J entity, indicating a small business under the SBA’s 8(a) Business Development Program or similar socio-economic designation. The company is headquartered in Saint Paul, Minnesota, with no publicly listed certifications. Its geographic footprint appears concentrated in the Upper Midwest, with a government market presence likely centered on defense health, VA, or NIH-related contracts. The firm’s profile suggests a specialized, agile provider focused on high-compliance medical technology domains, though its full scope of operations remains undefined by available performance data.

Key performance metrics

Award counts and award dollars by type, as prime and as subcontractor.

Awards Count

2

All time

Active

0

Currently performing

Completed

2

Past period of performance

Total Awards

All time

Contracts

Prime · all time

Subcontracts

Sub · all time

Grants

Prime · all time

Subgrants

Sub · all time

Award analytics

Awards by agency, industry, year, award type, size, and place of performance.

Awards by Agency
Awards by NAICS
Awards by Agency Over Time
Awards by Place of Performance

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NAICS: 541715
SBIR / STTR
NIH Small Business Technology Transfer Grant (Parent STTR [R41/R42] Clinical Trial Optional)
Solicitation # PA-27-102
The NIH Small Business Technology Transfer (STTR) grant, solicitation PA-27-102, provides early-stage funding to United States small business concerns (SBCs) to conduct research and development for commercial products in formal collaboration with non-profit research institutions. The program is designed to enhance health and reduce illness through a phased approach: Phase I focuses on establishing technical merit and feasibility, while Phase II advances the research toward commercialization. Eligible applicants include U.S.-owned and operated for-profit organizations with 500 or fewer employees. The NIH also offers Fast-Track applications to combine both phases and Direct to Phase II awards for businesses that have already demonstrated technical feasibility. Funding limits vary by the awarding NIH Institute or Center, with Phase I budgets typically ranging from 400,000 to 700,000 dollars and Phase II budgets reaching up to 3,000,000 dollars. Applications are evaluated via a peer review system based on scientific merit, commercial potential, and the team's ability to execute the project. While clinical trials are generally optional, they require a specific regulatory plan and adherence to strict safety and registration guidelines. Additionally, recipients must maintain active SAM and UEI registrations and comply with federal cybersecurity incident reporting requirements, including notifying the HHS of any breaches within 48 hours.
Department of Health and Human Services

POSTED

6 months ago

DEADLINE

in 5 months
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NAICS: 541715
SBIR / STTR
NIH, CDC and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Optional)
Solicitation # PA-27-100
The NIH, CDC, and FDA Small Business Innovation Research (SBIR) Grant, solicitation PA-27-100, provides early-stage funding to United States small business concerns (SBCs) to conduct research and development for commercial products. The program is structured in phases, with Phase I focusing on technical merit and feasibility and Phase II advancing the technology toward commercialization. Eligible applicants include for-profit U.S. businesses with no more than 500 employees. The funding opportunity accepts Phase I, Phase II, Direct to Phase II, and Fast-Track applications, with budget limits varying by participating institute, typically ranging from 400,000 to 700,000 dollars for Phase I and up to 3,000,000 dollars for Phase II. Applications are evaluated through a peer review system based on scientific and technical merit, significance, and the suitability of the business environment. While clinical trials are generally optional, they are prohibited for specific components, including all FDA participating components and several NIH institutes. Recipients must adhere to strict compliance requirements, including maintaining active SAM registration, disclosing foreign relationships, and implementing cybersecurity incident reporting procedures that notify agencies within 48 hours of discovery. The current solicitation remains open for applications until April 6, 2027.
Department of Health and Human Services

POSTED

6 months ago

DEADLINE

in 5 months
View Details
NAICS: 541715
SBIR / STTR
SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Optional)
Solicitation # PAR-27-098
The SBIR/STTR Commercialization Readiness Pilot (CRP) Program, under solicitation PAR-27-098, is a funding opportunity provided by the National Institutes of Health (NIH) to help U.S.-based small business concerns transition technology from late-stage development to full commercialization. This program specifically targets recipients of prior active or ended NIH SBIR/STTR Phase II or Phase IIB Strategic Breakthrough awards. The CRP supports activities that bridge the gap to market, including late-stage research and development, independent replication of key studies, manufacturing scale-up, and technical assistance such as regulatory strategy, intellectual property planning, and market research. While significant outsourcing to contract research organizations is permitted, the small business must maintain a substantial role in project oversight and management. Eligible projects may have a maximum performance period of three years, with budget ceilings varying by the participating NIH Institute or Center, ranging from 500,000 dollars to 2 million dollars, or following SBA guidelines for certain institutes. Applications are evaluated via the NIH peer review system based on scientific and technical merit, commercial potential, and relevance to program priorities. Key requirements for applicants include maintaining active SAM and UEI registrations and submitting a detailed regulatory plan and progress report. It is important to note that while clinical trials are generally optional, several NIH components, including the NHLBI, NIAID, and NIDDK, do not accept clinical trials under this specific funding opportunity. Additionally, funds cannot be used for patent or FDA filing fees, nor can they include separate Technical and Business Assistance funding.
Department of Health and Human Services

POSTED

6 months ago

DEADLINE

in 5 months
View Details