Advancing Healthcare Breakthroughs Transforming Patient Care

VC-backed startups are pioneering breakthrough technologies that improve patient outcomes, reduce healthcare costs, and expand access to care. From non-invasive therapies and advanced medical devices to AI-enabled diagnostics and precision medicine, entrepreneurs are driving a new era of healthcare innovation that strengthens both public health and economic competitiveness. 

The U.S. has long been the global leader in medical innovation because it combines world-class research institutions, entrepreneurial talent, and risk capital. Venture-backed companies play a critical role in translating scientific discoveries into life-changing products and therapies.  

To maintain America’s leadership in healthcare innovation, policymakers must ensure that startups can:  

• Access the capital needed to scale breakthrough technologies 

• Navigate efficient, predictable regulatory pathways that bring innovations to patients more quickly. 

• Continue investing in the next generation of medical discoveries. 

Startup Spotlight: HistoSonics is pioneering a new category of non-invasive treatment that uses focused ultrasound energy to mechanically destroy targeted tissue without surgery, radiation, or incisions. The company’s technology represents the type of breakthrough innovation that emerges when scientific research, entrepreneurial talent, and venture capital come together to solve complex healthcare challenges. 

As HistoSonics works to expand the use of histotripsy across a broader range of diseases and conditions, policies that support efficient FDA review pathways, predictable reimbursement systems, strong research partnerships, and continued investment in medical innovation will be essential to helping patients gain access to transformative new therapies. 

By the Numbers:  

• 62% of new medicines from 2013-2022 originated from VC-backed companies 

• Nearly 20% of all U.S. venture capital investment in recent years has been directed toward healthcare and life sciences companies. 

Policy Priorities

Accelerating FDA Approval and Patient Access: Healthcare innovators need predictable regulatory pathways that allow breakthrough technologies to reach patients quickly while maintaining rigorous safety and efficacy standards. Delays in approval and reimbursement can slow innovation and limit patient access to life-saving treatments. 

NVCA supports efforts to streamline FDA approval and reimbursement pathways for innovative therapies and technologies, including advancing the Ensuring Patient Access to Critical Breakthrough Products Act and advancing solutions like the RAPID Coverage Pathway. 

Building an AI-Ready Healthcare Ecosystem: Artificial intelligence is becoming increasingly important in healthcare research, diagnostics, drug development, and clinical decision-making. However, the healthcare ecosystem requires high-quality data and clear regulatory guidance to fully realize AI’s potential. 

NVCA supports establishing standards that ensure biological and healthcare data are AI-ready, including requirements for federally funded research. NVCA also supports clear FDA guidance for AI-enabled medical devices to provide innovators with regulatory certainty while protecting patients. 

Strengthening Incentives for Medical Research and Development: Breakthrough therapies and medical technologies often require years of research and significant capital investment before reaching patients. Policymakers should ensure that the United States remains the most attractive place in the world to invest in healthcare innovation. 

NVCA supports restoring small molecule exclusivity to 13 years to strengthen incentives for medical research and development and encourage continued investment in next-generation therapies and treatments. 

Expanding Public-Private Research Partnerships: Many of the most significant healthcare breakthroughs originate from collaboration between entrepreneurs, universities, research institutions, and federal agencies. Strong partnerships help translate scientific discoveries into commercial products that improve lives and strengthen U.S. competitiveness. 

NVCA supports expanding public-private partnerships across agencies, including ARPA-H, NIH, NSF, and HHS, to accelerate the development and commercialization of breakthrough healthcare technologies. 

Meet The Policy Expert

Ashlyn Roberts
VP, Government Affairs