Integrated Wound Care and Diagnostic Solutions for a Healthier Future.
Integrated Wound Care and Diagnostic Solutions for a Healthier Future.
ABOUT US
Pinnacle Biolabs is a multi-division life sciences and healthcare operations company providing laboratory consulting, PGX validation, wound care product distribution, and clinical reimbursement support. We help laboratories, physicians, and healthcare organizations grow compliantly, efficiently, and sustainably.
We combine biotech expertise, clinical operations, and regulatory compliance to deliver solutions that accelerate operational performance while meeting all federal and state guidelines, including EKRA, AKS, CLIA, and HIPAA.
What We Deliver
Laboratory Setup & Management (MSO Model)
Operational setup, workflow design, quality systems, and ongoing administrative support for CLIA-aligned laboratory environments.
Laboratory Assay Validation & Technical Support
Assay validation, workflow optimization, and technical support across Molecular systems (RT-PCR, ddPCR, Next-Gen Sequencing), ImmunoAssay, Clinical Chemistry, and Microbiology platforms.
Expertise includes infectious disease systems, pharmacogenomics (PGX), cancergenomics (CGX), autoimmune screening, and toxicology. We support FDA and LDT system design, troubleshooting, management/operations, and regulatory upkeep.
Wound Care Product Distribution & Reimbursement Support
Advanced wound care products backed by utilization guidance, documentation support, and reimbursement process optimization.
Compliance-Driven Operational Solutions
SOP development, internal audits, regulatory readiness (CLIA, HIPAA, EKRA, Stark), and quality-system support to maintain compliant operations.
Our Mission
At Pinnacle Biolabs, our mission is to advance healthcare performance through biotechnology, operational expertise, and regulatory excellence. We deliver diagnostic support, compliant laboratory operations, wound care product solutions, and reimbursement guidance that help providers deliver efficient, high-quality patient care.
Our Story
About Pinnacle Biolabs
Pinnacle Biolabs was founded by Anshuman Bakshi, a biotech innovator with more than a decade of experience in molecular diagnostics, laboratory operations, regulatory compliance, and clinical workflow development. What began as a focused consulting practice has grown into a multi-service healthcare platform supporting laboratories, physician groups, and wound care programs across multiple states.
Our organization was built to address three critical challenges in modern healthcare:
- Maintaining compliant, audit-ready operations
Providers and laboratories face increasing scrutiny across CLIA, CAP, HIPAA, Stark/AKS, and payer-driven guidelines. Pinnacle Bio Labs delivers structured, compliance-led workflows that reduce risk and support clean documentation practices.
- Launching, scaling, and optimizing laboratory operations
Many labs require expert guidance to validate assays, design workflows, develop SOPs, align staffing, and optimize reimbursement. We provide the technical and operational infrastructure needed for sustainable, compliant growth.
- Supporting physicians with reliable wound care and diagnostic solutions
Providers need integrated, clinically aligned solutions that enhance patient outcomes while reducing administrative burden. Our wound care distribution, PGX validation, and diagnostic services are designed for ease of implementation and compliant utilization.
Our Leadership Team
Anshuman Luv Bakshi - Founder & CEO
Anshuman Luv Bakshi is the Founder and Chief Executive Officer of Pinnacle Biolabs and Pinnacle Bioservices, bringing more than a decade of experience across molecular diagnostics, laboratory operations, healthcare compliance, and biotechnology innovation. A graduate of UC Berkeley with a degree in Molecular and Cell Biology specializing in Immunology and Pathogenesis, he has built a career at the intersection of science, clinical operations, and regulatory strategy.
Anshuman’s expertise spans molecular assay development, PCR/qPCR, sequencing workflows, DNA/RNA extraction, quality control, and troubleshooting across clinical, research, and production environments. His technical foundation is complemented by deep proficiency in federal medical policy, including LCDs, NCDs, prior authorizations, medical necessity criteria, appeals, and reimbursement structures. He translates these complex policies into practical, compliant solutions for laboratories, physicians, and healthcare organizations nationwide.
Throughout his career, Anshuman has supported laboratories through launch, scale, and restructuring—guiding teams through CLIA readiness, workflow optimization, staffing models, technology integrations, and operational performance improvements. His research experience includes work with the USDA and ASU’s Biodesign Institute, and he has also served in investor relations roles supporting biotech and drug discovery groups.
At Pinnacle Biolabs, Anshuman leads with a commitment to integrity, scientific rigor, and operational excellence. His multidisciplinary background positions the organization to deliver innovative, reliable, and compliant solutions across diagnostics, laboratory management, wound care operations, and clinical support services.
Michael Harrison - Chief Operating Officer
Michael Harrison is a seasoned operations and business development leader with more than 15 years of experience in commercial real estate, oil and gas project management, and strategic growth initiatives. He has worked across multiple industries, building strong partnerships and trusted business relationships throughout the United States and the United Kingdom.
Michael’s background includes overseeing large-scale commercial projects, coordinating investor engagements, and supporting executive teams through expansion and operational restructuring. His cross-industry insight and ability to establish long-standing client relationships make him a key driver of organizational performance.
As Chief Operating Officer at Pinnacle Biolabs, Michael oversees day-to-day operations, workflow efficiency, vendor coordination, and logistics. His operational leadership and broad business network play a central role in supporting Pinnacle’s continued growth across laboratory services, diagnostics, and wound care distribution.
Lisa Bakota - Strategic Operations / CFO Support
Lisa Bakota is a strategic operations leader with a strong background in marketing, finance, and regulatory compliance. She is the founder of Tres Group, LLC, a marketing and advisory firm that also provides investment advisory services and supports emerging businesses with growth strategy and operational guidance.
Lisa holds an MBA with a focus in International Marketing and completed her undergraduate studies at UCLA. She is a Registered Investment Advisor regulated by SEC and FINRA, and she maintains a California Real Estate Broker License, reflecting her long-standing commitment to ethics and compliance in regulated industries.
She also serves as a Board Member for We Are Game, a nonprofit focused on academic and youth development.
At Pinnacle Biolabs, Lisa supports financial operations, strategic planning, and partner relations—helping strengthen internal infrastructure and ensuring the company scales with clarity, compliance, and operational excellence.
Alexander Emami - Board Member & Executive Director, Strategic Partnerships
Alexander Emami serves as a Board Member for Pinnacle Biolabs, bringing extensive experience in biomanufacturing, biotechnology operations, and quality systems management. His background spans biologics production, process optimization, and large-scale operational oversight, supporting organizations focused on innovation, regulatory compliance, and sustainable growth.
Throughout his career, Alexander has contributed to the development and refinement of manufacturing workflows, technology integrations, and efficiency-driven production models across multiple biotech and life-science environments. His knowledge of GMP standards, quality control, and process engineering enables him to provide strategic guidance that strengthens operational performance and regulatory readiness.
At Pinnacle Biolabs, Alexander leverages his technical insight and industry perspective to support long-term planning, operational decision-making, and the advancement of diagnostic, laboratory, and wound-care initiatives. His strategic advisory role helps ensure the organization continues to evolve with scientific rigor, operational excellence, and a commitment to delivering compliant, reliable solutions to healthcare providers.
Cynthia Pierce - Board Member & Regional Vice President
Cynthia Pierce is an accomplished business leader with more than 20 years of experience advancing organizational growth, community engagement, and strategic partnerships across the Southwest region. She has held key roles supporting corporate development, nonprofit initiatives, and regional economic programs, earning a strong reputation for her ability to build high-value relationships and drive mission-aligned outcomes.
Cynthia has served on several boards and advisory groups throughout her career, contributing to initiatives focused on workforce development, community services, and regional business expansion. Her leadership experience spans foundation support, program coordination, and organizational outreach—making her a vital voice in guiding Pinnacle Biolabs Holdings’ broader community and strategic objectives.
In her dual role as Regional Vice President of Business Development and Board Member, Cynthia supports partnership development, regional operations, and organizational strategy. Her insight and commitment to collaborative growth continue to strengthen the company’s presence and impact across key markets.
Manish Bakshi - Board Member & Strategic Advisor
Manish Bakshi is an experienced strategic advisor with a long-standing background in international business development, investment planning, and organizational growth. He has supported companies across multiple sectors by providing guidance on market expansion, operational structure, and strategic capital pathways.
With well-established professional relationships throughout the United States and India, Manish brings a global perspective that helps strengthen partnership development and long-term investment strategy. As a Board Member and Strategic Advisor for Pinnacle Biolabs Holdings, he contributes to high-level decision-making, strategic alignment, and investor relations support — helping position the company for sustainable growth.
Why Pinnacle Bio Labs?
Why Healthcare Organizations Choose Pinnacle Biolabs
- Technical depth comparable to leading biotech firms
- Regulatory-first design across all services and solutions
- Cross-functional capabilities spanning Wound Care, Diagnostics, and Laboratory Operations
- Specialized expertise in PGX, molecular workflows, and clinical diagnostics
- Trusted partnerships with national manufacturers and physician groups
- Demonstrated success improving operational efficiency and reimbursement performance
- Support for a wide range of medical specialties and practice environments
Our Compliance Philosophy
Pinnacle Biolabs places compliance at the core of every service line.
All operations follow regulatory standards including:
- EKRA (Eliminating Kickbacks in Recovery Act)
- AKS (Anti-Kickback Statute)
- CLIA (Clinical Laboratory Improvement Amendments)
- HIPAA (Privacy & Security Rules)
- State-specific laboratory & provider regulations
Our approach ensures that clinics, labs, and partners operate with confidence, clarity, and protection.
To maintain legal compliance:
- We do not perform clinical laboratory testing.
- We do not offer percentage-of-revenue lab referral arrangements.
- We do not engage in direct patient solicitation.
- We do not operate outside the MSO management framework.
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