Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 409

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 409
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 reimbursement price has been agreed. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials in order to compare the cost effectiveness of a particular product candidate to currently available treatments. Other EU member states may allow companies to fix their own prices

for medical devices but monitor and control company profits. The downward pressure on health care costs has become intense. As a result, increasingly high barriers are being erected to the entry of new products.

In December 2021, Regulation (EU) 2021/2282 on health technology (“HTA”), or HTA Regulation, was adopted. The HTA Regulation will apply to medical devices as from January 2030. It particularly replaces the current system based on the voluntary network of national authorities, and the new framework covers joint clinical assessments, joint scientific consultations, the identification of emerging health technologies, and voluntary cooperation for the national authorities. The HTA Regulation aims to provide a transparent and inclusive framework for health technology assessments in the EU, and it will help EU member states determine the effectiveness and value of new treatments and decide on pricing and reimbursement by health insurers or health systems.

Healthcare Laws and Regulations

Physicians, other healthcare providers, and third-party payors will play a primary role in recommending, ordering, and/or prescribing any product candidates for which we obtain marketing approval. Our arrangements with healthcare professionals, principal investigators, consultants, customers, third-party payors, and others who purchase, recommend or prescribe our approved products, and our proposed sales, marketing, distribution and education programs are and will be subject to various federal, state and foreign healthcare fraud and abuse laws and other healthcare laws and regulations. The U.S. federal and state healthcare laws and regulations that impact our activities and operations include, without limitation, the following:

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 federal Anti-Kickback Statute, a criminal law, which prohibits persons from, among other things, knowingly and willfully soliciting,          
 receiving, offering or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of            
 an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federally            
 funded healthcare programs, such as Medicare and Medicaid. The term “remuneration” has been broadly interpreted to include                    
 anything of value. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order         
 to have committed a violation. Violations of