Our client are international and innovative medical technology companies in different development stages.
These companies are looking for an experienced partner to operate their organic or inorganic growth projects, in particular during transition times (i.e. US Market Access preparation, deal search or post-acquisition integration), when execution risks and time to market must be minimal.
Our clients' technologies fit in the Drug- Device & Diagnostics - Healthcare IT convergence space and are headquartered around the globe, in New Zealand, Singapore, France, Luxembourg, USA, Switzerland, Scotland etc...
Please find below a selection of our clients. Do not hesitate to contact us if you want to know more about these companies and their growth plans.
S14 Biospine Implants
For cervical, thoracic or lumbar spine surgery, S14Implants designs implants to treat degenerative spinal pathologies as well as deformities of the vertebral column, invents new concepts of dynamic stabilization overcoming the inter vertebral disc insufficiencies and invents growing implantable devices to correct without fusion the scoliosis of the young children. Some entry-level S14's products have obtained CE mark, and other advanced implants have been used in research for the past 3 years, with very positive outcomes.
MedNest Contribution: As a precursor activity to S14 US market entry, MedNest as studied the clinical relevance of S14's implants for the US healthcare system and secured several prestigious institutions for clinical trials. 7 Key Opinion Leaders have been engaged in very productive clinical, regulatory and business discussions that validated the potential of S14's implants in the US, but also enriched S14's clinical and regulatory strategy to enter the US. Next steps will be to trigger the regulatory plans (PME) and Clinical Plans (Protocol, IRB, deployment and implementation) to secure a successful evaluation, 510k approval and clinical adoption.
Activ Doctors Consult Venture Overview: In France, and soon in Europe, ActivíSante offers a service to provide a Second Medical Opinion in less than 48 hours. The engine of this service is based on (1) Electronic Medical Records and (2) access to a network of +700 medical leaders across Europe, with +150 KOLs in a large selection of therapeutic areas. With the emergence of Electronic Medical Records ($17B stimulus plan of 2009) and emerging concerns about the access to care and the quality of care in the US, medical Second opinion services, and in particular OnLine services are becoming very attractive services and venture opportunities. The strategic intent of Activ Sante is to enter this market, leveraging a contracted network of +700 medical specialists in France and Europe. MedNest Contribution: In close collaboration with the team at Activ Sante, MedNest has established a comprehensive industry, market, regulatory, legal and economic "calibration" of the US business opportunity for EMR-based services. Following the calibration, and comprehensive commercial and operational playbook was established. As a result of this preparation work, Active Doctor Consult was launched in November 2009 in Miami, FL, and is currenlty gearing up for growth.
Venture Overview: MicroTransponder is developing a wireless neurostimulation system for the treatment of chronic pain and several other neurological indications. The minimally invasive device will provide relief from chronic pain without requiring an implanted battery or wires. MicroTransponder also is adapting the system for Vagus Nerve Stimulation to create a pipeline of innovative treatments for other neurological indications, including stroke rehabilitation, tinnitus, autism, and Parkinsonís disease. MedNest Contribution: MedNest was asked to assess the company technology, regulatory and clinical position and recommend a propose a roadmap to accelerate 510k at minimal clinical cost. MedNest completed a comprehensive technology and clinical audit, redefined the product multigeneration plan and clinical intents, identified predicates (510k and PMAs) and established predicates comparisons, identified and procured all the relevant regulatory guidelines to create a robust regulatory framework and as a result of this pre-work, proposed a creative regulatory path ( PMA paned as predicate for 510k) and a pre-clinical and clinical plan ( protocol synopsis) to support a 6 month regulatory pathway.
Voluntis, Therapeutic Software Companions
Venture Overview: Voluntisis a digital health company. Its mission is to improve the real-world value of therapies by providing patients and healthcare professionals with therapeutic companion software. Its mobile and cloud solutions embed real-time decision support algorithms that empower patients to actively manage their medication therapy in remote collaboration with their healthcare team.
MedNest Contribution: In collaboration with a Medical Advisory Board selected from key Opinion Leaders from the Joslin Diabetes Center Network (Harvard Medical School, Boston), MedNest has collected the key specifications required for a diabetes solution dedicated to the US market and issued the initial "Design Input Document".
Venture Overview: MP5 is a pharmaceutical contract manufacturing company dedicated to the development and the manufacture of pre clinical and clinical batches containing highly potent and biotech drugs. With GPM facilities in France and excess capacity, MP5 offers a unique experitise and extremely solid track record at a time where high potency biopharmaceutical are becoming the driver of the oncology pipelines renewal around the globe. In addition, its sister company CREAPHARM enriches the portfolio of services needed after fill and finish to document and distribute the active compounds to clinical sites in the US and in Europe. MedNest Contribution: Following a detailed business opportunity calibration for MP5's expansion in the US, MedNest created the Operational and Commercial Playbook of MP5 in the US. MP5 Services was launched in the US in August 2009. As a critical element of the launch, MedNest searched for the VP of Business Development for MP5Services and assisted for his On-boarding process. MP5 Services is now expanding in the US and serving an increased number of mid-sized biotechnology companies.
Company Overview: Nexus6 Limited is a privately held New Zealand based developer and manufacturer of solutions to increase patient adherence to respiratory medications, leading to improved disease management and reduced healthcare costs. Nexus6's Smartinhaler devices monitor and report patients? medication usage to their healthcare partners, and are used in pharmaceutical clinical trials and respiratory disease management applications for chronic obstructive pulmonary disease, asthma and cystic fibrosis. SmartinhalerLive uses wireless communications technology to provide real time data collection and reporting from drug delivery devices. MedNest Contribution: MedNest has segmented and profiled the market and clinical opportunities for SmartInhaler in the US. Following this "calibration" phase, the segment of Respiratory Clinical Research has been targeted (Value proposition creation, Partnership search) to establish Commercial and Technology Partnerships. MedNest is currently looking for (1) financial and clinical partners to run an economic trial with the SmartInhaler and (2) Medical Device companies interested to partner and use the Live Technology to embed wireless remote monitoring technology into their devices.
AXS Ingenierie Company Overview: AXS Ingenierie is a diversified technology company, wit activities in aerospace, infrastructure and Medical Technologies. AXS is the winner of the prestigious Innovation Award for its new product, BIOMOD 3S The product is a medical device for computer-aided therapeutic decision allowing a relevant 3D analysis of spinal deviations, using images obtained from any standard radiological set up. MedNest contribution MedNest has identified major markets opportunities for BIOMOD3S and established the detailed roadmap to launch BIOMOD3S in the US: clinical sites for In Country Clinical validation, Regulatory Roadmap supported by well selected predicates. Raising $2-$4M to prepare US market entry (510k, Clinicals, KOL evangelization) in 2009 and full launch in 2010.
Company Overview Lutronic is a technology based company located in Rodange - Luxembourg - and is developing micro RFID tag solutions operating at 13.56MHz. NONATECs first application is an identification and traceability solution for laboratories. The patented micro tag with its integrated RFID chip, is manufactured on a fully automated production line at a Lutronic International subsidiary, which is an ISO 9001-2000 certified facilities, using state-of-the-art technologies. Markets to be targeted in the future will include luxury goods counterfeiting, industrial products tracking and medical implants identification.
MedNest contribution MedNest is currently developing the business of Nonatec in the Medical Technology field. After a detailed segmentation of the opportunities, MedNest is now building technology partnerships with major manufacturers of implantable medical device. Nonatec provides an elegant solution to the fore coming UIN FDA mandate and offers personalized (read/write through the skin) clinical follow up solutions for implantable devices or high end Life Science personalized Diagnostics.
BiancaMed offers leading health technology solutions for monitoring everyday living. Increasing healthcare costs coupled with the rise in chronic conditions, increasing obesity and the rapid aging of the population, suggests that health management will need to shift from traditional institutional settings (such as hospitals) to people's everyday environments, including the home: BiancaMed's mission is to transform personal health by providing the ultimate convenience in personal health monitoring.
MedNest contribution MedNest is currently facilitating the evaluation of Biancamed's Remote Sleep Monitoring device for pre-clinical research (CNS) on lab animals.
Technology Overview: Perio Protectis a revolutionary new method to treat most periodontal disease (also known as gum disease, gingivitis or periodontitis) using an FDA-cleared medical device to deliver dentist-prescribed medications directly to the source of the infection. MedNest Deliverables: MedNest has established the strategic global expansion roadmap to bring Perio Protect's technology to a prioritized list of targeted countries in a phased way.
Company Overview: Moleacaims to pioneer the development of drugs that extend the benefits of traditional Chinese therapies into mainstream western medicine, to reach millions of patients suffering from neurological, cardio-vascular and aging conditions Current Contribution: MedNest has launched Neuroaid10, Moleac's first product, in the US as a dietary supplement to support neurological functions and established preliminary discussions with major players in the naturopathic industry to further expand Neuroaid10's growth in the US.