Gene And Cell Therapy Regulatory Consulting

Asset Sale – Fully Equipped Wellness & Fitness Studio An outstanding opportunity to acquire a turnkey wellness business! This asset sale includes all fitness and Pilates equipment, making it ideal for a fitness studio, personal training, or group classes. The space also features three private treatment rooms — perfect for physical therapy, acupuncture, beauty care, or other wellness services. Highlights: Complete set of fitness & Pilates equipment included 3 fully equipped private rooms for therapy or treatment services Ideal setup for a multi-service wellness center Clean, modern, and move-in ready Whether you're expanding your current business or launching a new venture, this is a rare opportunity to step into a fully operational space with minimal setup required.

Our client is a world leader in iris recognition technology with a large production capacity based in USA. They are a multinational corporation with a robust track record of selling its best-selling, award winning technology products worldwide. Clients include the UN, the US Department of Homeland Security, US Navy, US Marine Corps, the governments of India the Philippines, Kenya, and in the private Sector Northrop Grumman, InCadence and numerous others. The company has and continues to develop an ever-increasing range of technical applications for its products in a very large and rapidly growing market. Applications range from numerous physical security applications to blockchain and cryptocurrency applications. This firm owns 28 patents (24 registered and 4 pending) for its proprietary "iris matching algorithm, iris recognition in bright outdoors under sunlight" technology and security technology. Our client also has world-leading iris recognition technology to crypto wallet, which dramatically improves the security and convenience of digital assets on blockchain. In addition to multiple patents, our client also owns 10 trademarks. Our client's iris recognition algorithm was evaluated as the world's best technology at IREX I of NIST in the USA, and its excellence has been proven. They are one of few companies to provide a complete solution including SW and HW from iris image scanner to matching SDK on server with the world's best technology. This business has global references for the National ID projects of the Indian and Philippine governments They achieved the No.1 market share, including UN-affiliated organizations such as UNHCR and WFP, and these markets are expanding worldwide. Our client's tech and related device is the only iris camera system satisfying MOSIP SBI 2.0 requirements for authentication (many countries are utilizing the MOSIP platform for their National ID systems). Our client's unique and powerful technologies are registered and protected by global patents, enabling stable business development and expansion. The company offers a total data infrastructure solution (large or small data requirements) for Web 3.0 (Web 3.0 is the approach for a new iteration of the World Wide Web which incorporates concepts such as decentralization, blockchain technologies, and token-based economics). Their technologies are based on Blockchain, IPFS, and distributed storage of private keys (IPFS is a distributed file system that seeks to connect all computing devices with the same system of files. This means data can be securely shared for Know Your Customer and Anti-Money Laundering (KYC and AML) needs. This meets information sharing protocols between service providers and will lead to a new and open data economy. The ramifications are complete security for Bank information, Financial Transaction Data, Driving Data, SNS Contents, Health Information, Government/Education Certification, Insurance Information in short data stemming from virtually any source. Confidential Information Memorandum (CIM) is available upon receipt of our short online NDA. Financing: If the price and deal structure is right. Support & Training: Provided at no charge to enable a smooth transition Reason for Selling: World-wide expansion

Our client is offering a next generation, patented medical device for the treatment of internal hemorrhoids. The procedure is painless, non-invasive, requires no anesthesia, is conducted in under 2 minutes, and can be performed in any medical setting: a doctor's office, a surgery center, an endo suite, or a hospital. Our client's product is a small, disposable, medical device that eliminates hemorrhoids. A physician uses this device by deploying a tiny rubber band on the base of the hemorrhoid. This procedure is known as rubber band ligation, and it is the #1 recommended treatment for internal hemorrhoids by the American College of Gastroenterology. Patients no longer need to use ineffective creams or receive painful, invasive surgery. Our client's device offers a permanent solution for their hemorrhoids. The device is currently manufactured in the USA through an FDA approved, ISO 13485 contract manufacturer, who specializes in medical devices. The device is sold directly to physicians of different specialties, including gastroenterologists, colorectal surgeons, GYNs, urologists and primary care physicians. The biggest targeted audience are gastroenterologists. NDA is required to secure comprehensive Confidential Information Memorandum. Growth and epansion: Nearly half of adults over the age of 50 will develop symptomatic hemorrhoids. In the U.S. alone, an estimated 60,000,000 people have experienced hemorrhoid symptom(s) at some point in their lives. Annually, over 20,000,000 people in the U.S. use an over-the-counter hemorrhoid treatment and 75% report a reoccurrence. These patients no longer need to use ineffective creams or receive painful, invasive surgery. Our client's device offers a permanent solution for their hemorrhoids. Financing is if the price and deal structure is right, and support and training is provided as required. Facilities are Outlined in CIM. Reason for selling is that the owners wish to move on to other projects.

Patented Universal Tumor-Targeting Drug Delivery Platform Co. This pharmaceutical company has developed and patented a universal tumor-targeting drug-delivery platform that can improve the safety and efficacy of many existing chemo treatments, with the ability to target numerous different types of cancer. The technology encapsulates existing FDA-approved drugs inside lipid nanoparticles (liposomes or emulsions) coated with patented human-sourced antinuclear antibodies (ANA). The lipid nanoparticle provides long-term storage stability of the drug and controlled release of the drug over time at body-temperature, and is expected to improve the safety and efficacy profile of the drug, including passive accumulation at the tumor while not harming normal tissues. The Company's ANA, sourced from lupus patients, binds to nuclear material present in abundance in areas of necrosis (dead / ruptured cells) present in and around all solid tumors, thus anchoring the drug-filled nanoparticles at the tumor where the nanoparticle is designed to slowly release the drug directly on the tumor for more effect. As the Company's ANA is not tumor-marker specific, but rather targets necrosis present in solid tumors, the technology is designed to "universally" target many different types of cancer including breast cancer, lung, ovarian, colon, prostate, etc., as well as rare childhood cancers. The Company completed a successful proof-of-concept study at Children's Hospital using Ewing's Sarcoma transplanted in immunodeficient mice. Treatment with the Company's forumlation significantly inhibited tumor growth and extended survival times compared to control mice receiving no treatment or treatment with plain liposomal doxorubicin. The Company has been granted Orphan Drug Designation by the FDA on 2 of the lead drug formulations, providing FDA fee waivers, priority review, and 7-years exclusivity upon market approval. The orphan pathway also enables the potential for New Drug Approval after successful completion of Phase 2 studies, with Phase III data collected while in the market, thus significantly lowering the time and cost to market approval. This same drug inside the Company's tumor targeting delivery system will likely have potential to treat other pediatric cancers, and/or cancers in larger adult populations. As the Company's platform and ANA has the potential to improve the safety and efficacy of many existing FDA approved drugs or even compounds in development, the Company anticipates the potential for multiple licensing agreements with multiple pharmaceutical companies seeking to improve their existing portfolio and extend patient life as they advance into clinical stage. And as it may be possible to file for New Drug Approval following successful Phase II studies, the Company anticipates licensing potential at early clinical stage. Multiple exit opportunities exist with high impact & high ROI. The Company is seeking a supportive capital partner to maintain momentum up to $20M. Funding will be used to advance the lead drug through formal Investigational New Drug enabling studies towards New Drug Approval; estimating $3-5 Million now to advance into clinical studies. Preclinical / animal studies estimate ($3 - 5 Million and 12-18 months); follwed by potential combined Phase I-II clinical study in a rare cancer (approximately 2-3 years and $10M) to potential New Drug Approval, plus additional capital to advance additional drugs in the pipeline simultaneously, thus adding tremendous value to the Company's valuation. Valuations of pharma companies often exceed $100 Million valuation at Phase I (approx. 18 months), and New Drug Approval can exceed valuations above $1 Billion. The Company has numerous, improved high-impact cancer drugs advancing with proper support. NDA is required for comprehensive Confidential Information Memorandum crafted by ProNova Partners. Detailed Information Competition: Trying to improve existing therapies and develop novel approaches to hard to treat cancers. Growth & Expansion: Huge market potential. Financing: If the price and deal structure is right. Support & Training: Transition team included. Reason for Selling: Seeking supportive capital partners to take to the next level(s). .

An exceptional opportunity to acquire a leading International Early Childhood Development Company, renowned for its pioneering integration of digital content in early childhood education, with a strong emphasis on social, emotional, and intellectual development. Programs are offered in more than 20 languages and have an impressive presence in more than 30 countries. The Company’s solid track record of meeting demand and creating growth is backed by an extensive franchise/license network. The Company’s proven teaching models produce exceptional results that have garnered high satisfaction ratings among children and parents alike. Independent research validates the superior outcomes achieved through exclusive age-based programs, enabling children to accelerate their learning levels twice as fast as their peers. The foundation of the Company’s success lies in its Licensing and Master Franchise structure. This highly effective framework enables them to meet local needs and rise above competition; adapting to diverse regional markets, and catering to cultural nuances. With plans for further expansion, the Company is poised to strengthen its position as a global leader in education. The Company has taken intellectual property protection seriously, employing robust safeguards to protect its 95 international trademarks, and 49+ copyrights, via a fortified software registration system. Don't miss this rare opportunity to acquire a thriving global Education Company with a proven model, and a commitment to innovation. Seize the chance to make a profound impact on children's lives while unlocking unlimited potential for growth and success. NDA is required 626to secure a comprehensive Confidential Information Memorandum (CIM) crafted by ProNova Partners. Facilities: No facilities. It is all virtual. Competition: While operating in a fragmented industry with numerous competitors, what truly distinguishes this Company is its dedication to cultivating essential learning skills that can be universally applied across academic subjects, such as mathematics. By combining digital resources, interactive technology, curriculum development, and effective teaching methods, the Company has long been at the forefront of integrating digital content into early childhood learning. The result is consistently achieving remarkable outcomes and staying ahead of any competitor. Growth & Expansion: Numerous avenues for growth and expansion lie ahead, including: 1. Expand presence by appointing Master Franchisees in Latin America, Asia, and Africa. 2. Strengthen market coverage by adding franchisees to existing geographic territories. 3. Boost brand visibility through enhanced social media marketing strategies. 4. Enhance the current digital curriculum in alignment with the newest and most advanced technology platforms. 5. Explore opportunities to directly sell to US Schools, tapping into a mass market segment. 6. Capitalize on the demand for digital content by offering valuable resources to families. By pursuing these strategic initiatives, the Company can harness its potential for exponential growth and secure a prominent position in the industry. Financing: TBD if deal structure and terms are acceptable. Support & Training: To facilitate a seamless transition and ensure continued success, the Seller is committed to providing comprehensive training and is open to the possibility of remaining as an employee, subject to negotiation regarding salary, duration, and terms. Reason for Selling: The Seller believes that now is an opportune time to sell.

The business manufactures and maintains process controllers servicing the water/wastewater, industrial, and institutional markets. Products are used in nuclear power plants, universities, hospitals, steel mills, paper mills etc. Two contract manufacturers make the products. One makes the products, assembles and drop ships them directly to customers. The other ships parts for final assembly at the Company's HQ. The business model has reduced overhead and the need for larger facilities. The Company has been through several incarnations since the late 1800's and into the1900s when early models of process controllers were invented. This legacy of innovation was nearly lost when the 2004 buyers, a private equity group, failed to implement adequate management and oversight of operations. When purchased and a new LLC established in 2019, the operation was distressed; innovation stalled and engineering on hold. The current owner, an industry-insider, knew what needed to be done, reduced manpower redundancy, but saved jobs and inspired innovation once again. The value-add potential seen in restructuring; reducing overhead, implementing operational efficiencies and improvements resulted in increased bottom-line profitability and the business' gross margin. Detailed Information Facilities: The 7,500 square foot industrial/office space rents for $4,700 per month. The lease extends through May 2024. About half of the space is open warehouse with offices around the perimeter. Competition: Three large multinational corporations are the most predominate competitors in the market that cannot compete with on price thanks to the greater flexibility in pricing. This flexibility also means the ability to offer more customization options to the customer. Other than lower price points, the Company offers great support & application-based solutions. Excellent support, outstanding products and digital marketing, have helped grow market share in since 2019. Growth & Expansion: The Company is on track for gaining market share in a variety of categories of controllers, and with the pending release of the new a next-generation controller more opportunities will open. Additionally, the Company was been awarded a contract for an international nuclear project. In the future, greater overhauls in various industries will be needed to accommodate greater automations. Many new opportunities that will originate with engineering department. The team will create drawings, and design controller configuration. Domestic and international oil and gas industry applications are still strong; natural gas pipelines require compression, measuring and refinery stations. There will be more opportunity in renewable energy, as the industry becomes more streamlined. To ensure long-range goals are reached, the Seller recommends the Buyer focus on making R&D investments, keep new product pipelines growing, and increase spending in the sales & marketing departments. Financing: TBD if structure and terms are acceptable. Support & Training: To ensure a smooth transition and ongoing success the Sellers will work with a buyer as needed for three months, and longer as a paid part-time consultant, as negotiated. Reason for Selling: Seller enjoys restructuring companies, once stabilized, it's onto the next rescue project!

The Company has proprietary technology that addresses a leading cause of maternal death (76,000) and fetal death (500,000) annually worldwide. 8% of pregnancies in the US and 14% worldwide have diagnoses that would be vastly improved by worldwide commercialization of the Company's proprietary device. A very low risk procedure that both provides quality of life improvement for the mother & baby and lowers health care costs is a win/win/win for all involved. Existing collaborations with major manufacturers coupled with a current expedited approval process with the FDA presents a tremendous opportunity for individuals or private equity groups seeking a transformative investment into a feel-good biotech story with exceptional legs and a vast runway with nearly unlimited upside. Able to work with groups/individuals in tranches of $500k to $1M to advance into the pilot clinical study, $2-$3MM for the pivotal clinical study towards market approval in the US. They will seek direct sales with partnered hospitals, licensing / partnership deals could utlimately yield the balance of funding to fully deploy a commercial version of the technology. NDA is required for comprehensive Confidential Information Memorandum (CIM) crafted by us. Detailed Information Competition: No current option available besides bed rest. Growth & Expansion: Huge market potential. Support & Training: Full team included. Reason for Selling: Seeking supportive capital partners to take to the next level(s). .

Our client operates a lean, high-margin B2B lead-generation platform dedicated to the Internet of Things sector. By leveraging a permission-based community of over 60,000 vetted IoT decision-makers and a LinkedIn Group of 20,000+ approved professionals, they deliver turnkey sponsored webinars, white-paper campaigns, and targeted email blasts—providing technology vendors with consistently qualified leads while maintaining minimal overhead through a fully remote, contractor-driven model. NDA is required for comprehensive Confidential Information Memorandum (CIM) crafted by ProNova Partners.