The regenerative medicine market is expected to reach $49 billion by 2028 with a compound annual growth rate of 25.1%[1]. This substantial growth is fueled by the rise of personalized medicine, cash-pay services, and innovative services such as testosterone replacement therapy, hormone replacement therapy, and platelet-rich plasma injections.
While the regenerative medicine, anti-aging, and wellness industry continues to grow, so do the regulations governing them. Several states have implemented specific regulations tailored to these industries. While this burgeoning market offers lucrative prospects, participants must navigate carefully amidst evolving regulatory landscapes.
Frier Levitt’s healthcare, life science and pharmacy attorneys offer invaluable assistance to regenerative medicine practices, businesses, and industry stakeholders. Our team provides essential guidance to understand and adhere to federal and state-specific regulations, ensuring compliance and mitigating risks. Moreover, we offer support in structuring businesses to align with participants’ financial and investment objectives, empowering them to thrive in this dynamic industry.
Background
The Mayo Clinic defines “regenerative medicine” as medicine that is “focused on developing and applying new treatments to heal tissues and organs and restore function lost due to aging, disease, damage or defects.”[2]
Within the larger umbrella of regenerative medicine, providers routinely provide testosterone replacement therapy (TRT), platelet-rich plasma injections (PRP), and hormone replacement therapy (HRT).
As a national boutique law firm focused exclusively on providing legal counsel to the healthcare industry, Frier Levitt is uniquely positioned to advise our clients on the broad range of issues faced regularly by regenerative medicine businesses and medical practices focused on regenerative medicine. Our services include:
- Regulatory compliance
- Corporate transactions
- Formation of management services organizations (MSOs)
- Licensing agreements
- Drafting governing documents
- Development of tailored protocols
- Strategic guidance on telemedicine
- Intellectual property applications
- FDA and Board of Pharmacy inspection support
Regenerative Medicine Legal Services
Whether you are considering the expansion of your current medical practice to include regenerative medicine services, or you are interested in starting your own regenerative medicine practice or establishing an MSO to support a regenerative medicine practice, there are several legal and regulatory issues that must be addressed.
Frier Levitt’s healthcare and life sciences practice groups include regulatory and corporate transactional attorneys adept at advising clients with regard to the preparation of corporate documentation, the sale or purchase of regenerative medicine practices, and the preparation of other legal documents such as employment agreements, medical director agreements, governing documents and/or services agreements. We routinely assist clients with the formation of MSOs used to support regenerative medicine practices.
The team also includes attorneys focused on regulatory compliance who advise clients on issues such as state-specific restrictions on the scope of practice for physician’s assistants, nurse practitioners, advance practice nurses, registered nurses, and the types of services that may be provided by physicians, non-physician providers, and non-licensed providers (i.e. the types of providers who may inject).
Why Choose Frier Levitt?
Frier Levitt’s Regenerative Medicine, Anti-Aging, and Wellness lawyers provide legal advice to physicians and clinicians engaged in innovative anti-aging and wellness practices. Seeking sophisticated healthcare counsel is important for navigating the legal landscape for a successful launch, addressing legal issues when marketing these services, and state-by-state compliance. We can help equip your practice with the guidance necessary to thrive amid regulatory changes and evolving legal standards.
How Frier Levitt Can Help
Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you.
[1] Regenerative Medicine Market Size, Share, Trends and Revenue Forecast [Latest] (marketsandmarkets.com)
[2] About Regenerative Medicine – Center for Regenerative Biotherapeutics – Mayo Clinic Research
