Tutela Industries, LLC. United States

Tutela Industries is a Health IT startup developing patient-centric mHealth solutions to reduce readmissions and significantly enhance patient engagement. Tutela has developed a proprietary and breakthrough low cost, secure framework, TutelaConnect™, for hospital-based clinicians to communicate (voice, video, and data) securely to remote caregivers, both outside and inside the hospital environment. Even though a majority of hospitals have implemented electronic health records for identifiable patient data exchange within the hospital, the secure HIPAA compliant capture and exchange of unstructured patient information outside the hospital remains a challenge, impacting decision making, care coordination and informed consent.

In a recent benchmark data security report, over 90% report that their number one security risk is the unsecure exchange of patient information (phone, text. email) initiated from inside the hospital. 88% of hospitals attribute data breaches to employee negligence and the lack of mobile device security. The cost of these breaches exceeds $5.6 Billion per year, averaging $1M per year per hospital. Most hospitals are still struggling to create a unified communication strategy that meets stringent security, HIPAA compliance requirements while meeting clinical workflow and ease of use demands. Ubiquitous solutions are not cloud-based which makes the use case for patient engagement costly, complicated and difficult to scale. Ultimately, restricting the use to the few and not the many. The worldwide available market for interactive patient engagement solutions exceeds $2.3B and the initial target market, the high-risk Neonatal Intensive Care is estimated at $160 Million. The TutelaConnect™ Platform, can enter the market within current reimbursement and regulatory environments, and is ready to launch H2 2015 through sales to the first  pilot hospitals.

The competitive landscape includes large players in adjacent markets; Cisco/PolyCom for enterprise video solutions; Phillips, medical device manufacturer for remote monitoring, and electronic health record companies, Cerner and EPIC. Small niche players, Mommy’s Ear, Angels Eye and NICView offer limited pieces of a unified patient engagement communication tool.  None to date provide a cloud-based, platform agnostic, secure and HIPAA compliant method that eliminates costly licenses, expensive hardware and ongoing endpoint configuration and IT support requirements.

A strong competive position, highly differentiated use cases, a clear Freedom to Operate and patent potential, as well as, a highly experienced management team, early traction and favourable regulatory trends provide a great opportunity for success.

Website:
www.itutela.com
Year Founded
2010
Main Sector
Medtech Subsector
Indication
Biotech Phase of Development
Medtech Phase of Development
Technology Overview

In 2010, Tutela company founders observed that a great need existed in intensive care areas for clinicians to communicate with patient’s circle of care; family members, advocates and aids to streamline discharge processes, prevent readmissions and provide a better experience. After 1000+ technical, economic and user interviews, a minimally viable prototype was developed for use in high risk areas, such as the neonatal intensive care unit (NICU). Three of the more novel components of the system include a secure access distribution mechanism; role-based mechanism to authenticate all users (both inside and outside the hospital) and their relationship to a third-party(patient), a method in which the capture of all the information including users, 3rd party (patients), clinical notes, electronic health record information, and any voice, video or audio transmission is secured at rest and in transit fulfilling compliance regulations, and a method to capture, store, forward and assign all relevant data from each engagement session to a  3rd party (patient) eliminating licenses and user accounts. The TutelaConnect Platform provides the first multi-platformed, cloud-based interactive patient engagement system that securely connects remote care givers to the bedside of critically ill patients using a platform agnostic video conferencing technology.

Alliance & Collaborations
First three pilots and customers include; Johns Hopkins Hospital, University of Pennsylvania Children's Hospital, Georgetown University Hospital NICU. Discussions are underway with seed investors TEDCO(follow-on), Maryland Ventures and Gulf Ventures.
Supporting Metrics or Evidence

Strong evidentiary support that patient and family engagement plays a vital role in experience and outcomes exist including a direct correlation with patient satisfaction, discharge planning and reduced readmissions; Fairview, Cope and CMS studies. The ongoing clinical trial and the voice of customer data (1000+ technical, economic and user interviews) have shown a technical deployment in less than 15 hours at an academic medical center, an improvement in clinical efficiency in the record of unstructured communications, an increase in patient satisfaction that impacts reimbursement and a slight reduction in length of stay that saved the hospital, $13,000. Hard numbers will be available at the completion of the trial in Q1 2015. The system is considered a Class One Exempt device. The FDA requires only that the NICULink, mobile device and the TutelaConnect Platform be registered 30 days prior to commercialization.

Current Financing Needs

$800,000. Amount can be staged to support product development completion, headcount and pilot costs.

Current Timeline

6-9 months away from commercialization.

Current Investors

TEDCO($100k), Founders Capital ($300k) and Gulf Ventures(GVC)committed ($200k)

IP Status

Freedom to Operate Analysis and Provisional Patent was filed in December 2014.

Recent Milestones

To date, 90% of the first product platform has been developed. Technical and clinical workflow usability and feasability testing is complete. In December 2014, beta testing of a portable mobile device connected to the platform began in the NICU at Georgetown University Hospital. Over 500 clinician-to-family interactive video sessions have been completed with 97% "game changer" endorsement. A small reduction in length of stay, 3.9 days, equated to savings of $13,000 during a 3 week period. Additional pilots are lined up at Johns Hopkins and UPENN in the adult and pediatric service lines, which will lead to first sales A committment for $200k was received in December. A pipeline and contact with other interested hospitals including Loma Linda, Stanford, University of Tennessee has been initiated. Soft product launch is targeted for October 2015 at a national neonatal conference.  

Management Team Highlights

We have an experienced and well rounded team with 80+ years expereince in network security, medical device and software product development and clinical data support sales and marketing. Brad Pollard, CTO, has 15+ years in startup expereince. His last position prior to Cisco was with Source Fire, sold to Cisco for $2.3B. Karen Alder, CEO, has 20+ years in sales and accounting with health IT startups. Her last position was with TheraDoc, which was sold to Premier for $117M. Richard Smith, COO, 25+years experience in medical device product development. Led successful product launches at GE and Brainz. Brainz was successfuly exited in 2008. Clinical advisors are well recognized leaders in neonatology and the adult critical care space.

Karen Alder
Co-Founder/CEO 

VisionScope Technologies United States

VisionScope Technologies (VSI) is an early stage medical device company utilizing state of the art video hardware, micro-optics (1.4mm) and advanced computational software to bring arthroscopic imaging to the surgeon’s office. The company’s VisionScope Imaging (VSI) system brings gold standard accuracy into the clinic, providing surgeons with direct visualization of patients’ joint space – views that could previously only be achieved in the operating room – providing better outcomes at a lower cost to both MRI and OR based diagnostics.

 Benefits of VSI:    

·     High definition quality of a VSI diagnostic can eliminate the need for a MRI and rule out OR based diagnostic surgery

·     More detailed and accurate than a MRI for joint conditions

·     Significantly reduces the cost of care for individuals and overall healthcare systems

·     Patient centric exam – the patient participates in treatment discussion

Website:
www.myvsi.com
Year Founded
2007
Main Sector
Medtech Subsector
Medtech Phase of Development
Technology Overview
A needle endoscope (1.4mm diameter) houses a miniature fiberscope which allows complete inter-capsular diagnostics in a physician office setting. The endoscope is gently inserted into the joint space (capsule) with pictures and video projected onto a monitor for both the physician and patient to observe. The diagnostic takes place in an office exam room with only a local anesthesia (Lidocaine.) The exam takes less than 10 minutes and requires no stitches or recovery time.
Alliance & Collaborations
None
Supporting Metrics or Evidence
A multi-center, prospective, blinded clinical trial compared the accuracy and efficacy of VSI to MRI and surgical arthroscopy in the diagnosis of knee pathologies. The results: VSI is statistically equivalent to surgical diagnostic arthroscopy (the gold standard) and significantly more detailed and accurate than MRI.
Current Financing Needs
Seeking equity investments
IP Status
24 Issued patents on the core technology
Recent Milestones
Pivotal trial presentation at AOSSM (American Orthopaedic Society for Sports Medicine)
Management Team Highlights
The leadership team has substantial orthopedics and med tech experience at Zimmer, Stryker, J&J DePuy (Hand Innovations), Intuitive Surgical and J&J Mitek (Innovasive Devices)
Hjalmar Pompe van Meerdervoort
CEO