Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 379

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 379
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Our human capital resource objectives include identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants. The principal purposes of our equity incentive plan are to attract, retain and reward personnel through the granting of stock-based compensation awards, in order to increase stockholder value and the success of our company by motivating such individuals to perform to the best of their abilities and achieve our objectives.

We currently have no employees. Cerevast currently has three full-time employees that will join the Company after completion of the Business Combination.

We anticipate that the number of employees will grow as we scale our research and development and clinical organizational capabilities. In addition, we utilize and will continue to utilize consultants, clinical research organizations and third parties to perform our analytical and test method development, component and sub-assembly design and manufacturing, as well as preclinical studies, clinical studies, manufacturing and certain regulatory functions. We will use consultants and third-party analytical and design houses to complement internal capabilities and will utilize external manufacturing partners that have extensive experience in drug and medical devices and dealing with regulatory bodies to provide API, clinical drug material, components, assemblies and final product. Our suppliers will have ISO 13485 approved quality systems or have been approved for GMP manufacturing of pharmaceutical products.

None of our employees are represented by a labor union or covered by collective bargaining agreements.

We consider our relationship with our employees to be good.

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Government Regulation

We anticipate that our LBI-201 Aureva TMPulse product candidate will be regulated as a medical device. We anticipate that our LBI-001 Reflow RVO TMproduct candidate will be regulated as a drug/device combination product and our LBI-101 soft tissue reconstruction product will be regulated as a biologic.

Medical Device Regulation

United States

Medical devices are subject to extensive and ongoing regulation by the FDA under the Federal Food, Drug, and Cosmetic Act (“FDCA”), and its implementing regulations, as well as other federal, state and local regulatory bodies in the United States and comparable authorities in other countries under other statutes and regulations. The laws and regulations govern, among other things, product design and development, preclinical and clinical testing, safety, efficacy, manufacturing, packaging, labeling, storage, recordkeeping and reporting, premarket clearance or approval, marketing, distribution, promotion, advertising, import and export and post-marketing surveillance. Failure to comply with applicable requirements may subject a device and/or its manufacturer to a variety of administrative or judicial sanctions, such as FDA refusal to