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Category Archives: News
Quest Diagnostics Adds Diabetic Retinopathy Screening Through its Patient Service Centers in Collaboration with IRIS
New Capability Enables Individuals Identified as High-Risk by Participating Health Plans to Access Screening through a Quest Diagnostics Site
Builds on Quest’s Extended Care Services to Improve Care Quality and Outcomes in Diabetes and Other Chronic Diseases
Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, today announced a collaboration with IRIS (Intelligent Retinal Imaging Systems) to deliver diabetic retinal imaging services through designated Quest Diagnostics patient service centers across the United States to aid in screening patients for retinal assessment by a healthcare provider. The collaboration aims to increase convenience and improve screening rates for diabetic retinopathy, the leading cause of blindness in the United Statesi, for members of population health management programs sponsored by health plans.
According to the Centers for Disease Control and Prevention, nearly one-third of patients with diabetes over 40 years old have diabetic retinopathy.ii Screening to aid early detection and treatment may help prevent the disease from progressing to blindness.iii While an annual diabetic retinal screening is medically recommended for patients with diabetes, barriers to care can limit access to this service.
In 2018, Quest Diagnostics, through its Quest HealthConnect (QHC) business, began to provide diabetic retinal imaging for use in screening using the IRIS platform. This platform involves the use of a portable, handheld camera that captures a patient’s retinal images as part of its risk evaluation and care services for participating health plan members. The new collaboration with IRIS extends the use of the IRIS platform at Quest’s patient service centers.
New service builds on Quest’s vision to aid in closing gaps in care for patients with diabetes
The new service expands on the Quest Diagnostics Extended Care portfolio of services designed to facilitate access to care beyond traditional healthcare settings. These services feature home-based risk assessment and monitoring tools through Quest HealthConnect and coaching for chronic conditions through Pack Health, which Quest Diagnostics acquired in January 2022. It also includes services provided by Quest Healthcare Analytics, which utilizes the company’s database of 60 billion laboratory test results to help identify and engage at-risk members for health plans to close screening gaps and improve care quality and outcomes.
With training developed by IRIS, designated personnel at Quest patient service centers will transmit a patient’s retinal image to a credentialed, licensed ophthalmologist to interpret the images. The IRIS Program returns a diagnostic and patient report to Quest HealthConnect. The results are also transmitted to the health plan as well as the patient’s primary care physician or eye specialist for follow-up diagnosis and care.
“Limited access to important screenings has allowed the undetected, sight-threatening progression of diabetic retinopathy to grow,” said Christopher Grant, Vice President & General Manager, Quest HealthConnect. “Through this collaboration with IRIS, we can now provide a new opportunity to help prevent sight loss. Leveraging our network of patient service centers will increase access to screenings for many, ultimately leading to better health outcomes.”
“IRIS is thrilled to be joined by Quest Diagnostics, the nation’s leading provider of diagnostic information services, to help mitigate preventable blindness,” said Steve Martin, IRIS CEO. “Through this expanded care network, it will make it much easier to reach the estimated 60% of people with diabetes that are currently skipping their annual diabetic retinopathy check.iv”
Diabetic retinopathy is caused by damage to the blood vessels in the retina and can lead to vision loss or blindness in diabetics. Early detection and treatment of diabetic retinopathy is crucial to slowing disease progression and preventing patients from losing their eyesight.
YPrime Acquires Tryl, a Patient Engagement Solutions Company, Adding More Capabilities to Support Decentralized Clinical Trials
Malvern, PA, February 8, 2022 – YPrime, LLC, a global leader in cloud-based eClinical solutions, announced today the strategic acquisition of Tryl, a software development company with a unique patient engagement solution that brings together beautiful design, dynamic personalization, and applied behavioral science that is designed to boost engagement, reduce dropouts, and deliver outcomes in clinical trials. The acquisition includes the transfer of all staff, development capabilities, and intellectual properties to YPrime, and will integrate with YPrime’s Patient Engagement Technologies solutions.
“YPrime’s major priority has always been to anticipate the needs of tomorrow’s clinical trials and create powerful eClinical tools that simplify the lives of sponsors, sites, and patients,” says Shawn Blackburn, CEO, YPrime. “This combination with Tryl helps us leap ahead in fulfilling our vision of creating the industry’s first-of-its-kind solution to help keep patients more informed and engaged throughout the entire clinical trial process, especially as our industry accelerates toward decentralized clinical trial models.”
“An ever-increasing focus on patient centricity demands an integrated approach to how patients are engaged,” says Ian Greenfield, CEO of Tryl. “This starts from the moment patients are recruited and continues throughout the entire patient journey. YPrime has a strong vision for the future and by bringing together offerings from our two companies, we can create a novel solution that takes head on the most pressing challenges associated with attracting, engaging, and retaining patients.”
Tryl’s tools provide an experience that is personalized, predictive, empathetic, and relative to the overall patient journey. Tryl’s proprietary engagement score is designed to reduce patient dropout rates. Rooted in consumer experience, the Tryl team applies proven behavioral principles from other industries (such as professional sports and consumer finance) to seek to improve patient adherence to study protocols.
Mark Maietta, President, YPrime expressed his enthusiasm, “The addition of the Tryl team and their innovative solutions will boost patient compliance and reduce attrition, and the timing is perfect. YPrime has built an enviable market position with its strong eCOA and IRT capabilities. Now we can seamlessly layer on complementary solutions to our innovative technology stack for running successful decentralized trials.”
Tryl applies a consumer-grade UX and proven behavioral techniques like design thinking, empathy, and social proof, to increase study compliance and guide participants through complex protocols. Predictive analytics prompt clinicians to step in before subjects drop out. This approach minimizes participants’ burden while maximizing value for sponsors and researchers.
Source: GEN – Genetic Engineering & Biotechnology News
Neutralizing antibodies represent an important class of therapeutics that could provide immediate benefit in the treatment of SARS-CoV-2 or as a passive prophylaxis before vaccination. Passive prophylaxis also could be an alternative to vaccination in populations where vaccines have been found to be less efficacious.1
When AbCellera became a participant in DARPA’s P3 (Pandemic Prevention Platform) program in 2018, the aim was to build a pandemic-ready, rapid response, antibody discovery platform capable of developing field-ready medical countermeasures within 60 days of isolation of an unknown viral pathogen. At the time, AbCellera didn’t know that within two years its platform and team would be mobilized to react in record time to a real-life global health scenario, the COVID-19 pandemic.
In every person’s body, billions of antibodies exist, each with unique properties and functions. AbCellera’s full-stack AI-powered antibody discovery platform deeply searches natural immune responses to identify antibodies with desired properties such as virus neutralization, safety, longevity, and manufacturability.
The company’s mission is to make its technology stack available and to empower all antibody-based drug discovery programs. To date, the technology stack has been used in over 100 programs to address a wide range of indications in addition to COVID-19 and other infectious disease.
Putting a plan into action
At the end of February 2020, AbCellera obtained a single blood sample from a recovered COVID-19 patient. Close to six million peripheral blood mononuclear cells (PBMCs) were screened in three days, and thousands of therapeutic antibody potentials eventually narrowed to a final subset of 500 unique antibodies that recognized the interaction between the SARS-CoV-2 spike protein’s receptor binding domain (RBD) and the angiotensin converting enzyme 2 (ACE2) cellular receptor.
These candidates underwent extensive analysis and characterization—approximately 500 data points per molecule. An important aspect of the technology stack is the machine learning/artificial intelligence (ML/AI) tool that allows analysis of large data clouds comprised of approximately 250,000 data points for this data set.
“We were able to visualize the analysis and down selection process using our custom in-house visualization software, Celium,” said Ester Falconer, PhD, chief technology officer at AbCellera, who led the AI-powered antibody discovery platform’s development.
Bryan Jones, PhD, senior research fellow at Eli Lilly and Company, co-led most of the discovery activities that took place at Lilly, in close partnership with AbCellera. His group played a large role analyzing and transitioning the initially discovered set of hundreds of antibodies—through selection, production, and characterization of a narrowed set of antibodies—that ultimately led to the identification of LY-CoV555 (bamlanivimab) for clinical development.
“Due to the rapidly evolving and geographically diverse nature of the SARS-CoV-2 virus, continued scientific innovation remains critical to develop additional treatments,” said Jones, who adds that Lilly remains committed to developing complementary neutralizing antibodies to address potential SARS-CoV-2 variants that undoubtedly will arise. Currently, a next-generation antibody, LY-CoV1404, is in the preclinical pipeline.
Intense pressure and challenges
“Our platform and the extended team were ready,” said Falconer. “But in reality, this was a new virus that the world was racing against. We had no experience with it and did not know what type of immune response it would elicit. To develop an antibody database to mine, we had only one blood sample from one of the first recovered patients in the United States.
“Plus, this was an early immune response. The blood was drawn 20 days after onset of symptoms. It was not clear what we were going to find. We had one shot, it had to work, and it had to be the fastest discovery ever. The pandemic-ready platform and team had to deliver.”
The speed at which things needed to progress was the biggest challenge. “Because of the urgency,” Jones recalled, “we were making decisions based on little data and testing a new virus, while simultaneously trying to coordinate these activities across multiple organizations ranging from Lilly and AbCellera, to the Vaccine Research Center (VRC) at the National Institutes of Health (NIH), to the numerous academic collaborators who were providing critical data.”
All of these efforts played out against a backdrop of everyone trying to learn how to work nearly completely remotely.
Antibodies were characterized deeply to ensure that any data points that could direct the team in the right direction would not be overlooked. The number of data points per antibody highlights the importance of the visualization software Celium and the infrastructure AbCellera developed to generate, aggregate, and process the data. High-stakes decision making was made in real time.
The discovery efforts, which have been detailed in Science Translational Medicine, included the rapid identification and characterization of the potent anti-spike neutralizing antibody, LYCoV555, derived from PBMCs isolated from a patient after recovery from COVID-19.1
It takes a village
“With the right team and technology, what seems impossible is achievable. With Lilly, we broke the mold for the fastest discovery through IND for any drug, challenging the current drug development process,” Falconer said. “It does not need to take years and years. Nearly six million cells were screened in three days, antibody genes were sequenced in an additional two days, and antibodies were generated and tested a week later—an incredible feat.”
“There really was not a tremendous difference in the workflow of discovery, clinical development, and manufacturing, except that everyone was singularly focused,” Jones added. “But a key difference was partnership with the FDA to identify innovative approaches to get treatments to patients as quickly as possible. We learned that a large and committed group of people concentrated on a sole objective can do amazing things.”
Pandemics are unpredictable
Bamlanivimab proceeded from sample to Emergency Use Authorization (EUA) in just over eight months, a groundbreaking achievement in the development of antibody therapeutics. In November 2020, the FDA granted an EUA for bamlanivimab alone, and subsequently granted an EUA in February 2021 for bamlanivimab together with etesevimab (LY-CoV016), for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Due to the sustained increase of SARS-CoV-2 variants that are resistant to bamlanivimab alone, Lilly requested and received in April 2021 a revocation of the EUA for bamlanivimab used alone. The EUA remains in effect for the combined use of bamlanivimab and etesevimab.
The Carterra LSA facilitated the rapid kinetic characterization of the selected recombinantly expressed antibodies to the SARS-CoV-2 spike protein and the RBD.
Spike protein–dependent viral entry is initiated by upward movement of the RBD at the apex of the protein, allowing access to bind the ACE2 cellular receptor. Upon receptor engagement, coordinated proteolytic cleavage and shedding of the S1 subunit occur, and conformational rearrangement of the S2 subunit leads to viral fusion with the cell and transfer of genetic material.1
“The LSA allowed for an extensive epitope analysis to be performed on the antibody panel which demonstrated broad epitope coverage, distinct classification into known binder categories such as S1 and S2, and the determination of neutralization of ACE2 binding,” said Dan Bedinger, PhD, applications scientist team lead at Carterra.
These assessments were key elements in the ranking and selection of the subset of leads for further characterization.
The ability to rapidly complete these analyses in a parallel, unattended fashion with minute amounts of recombinant antigen—a scarce and valuable resource—made it possible to characterize the full candidate panel in an extremely accelerated development timeline, 90 days from initiation to first in human.
According to Bedinger, no other bioanalytical platform could have provided this rich picture of epitope binning classification, a picture that delivered a deep understanding of the interaction between sequence diversity and epitope recognition.
Coronavirus Immunotherapy Consortium
As variants of SARS-CoV-2 emerge, Carterra is collaborating with the Coronavirus Immunotherapy Consortium (CoVIC), a Gates Foundation–sponsored program. CoVIC has collected nearly 300 antibodies from a wide variety of sources that target the SARS-CoV-2 spike protein.
In a highly interdisciplinary effort across many institutions, these antibodies are being evaluated for a variety of properties including viral neutralization and escape, effector function, epitope recognition, and binding specificity. The LSA is being utilized to characterize the relative binding of each antibody to a variety of spike mutants and to create a comprehensive epitope binning profile.
“Data show that these antibodies can be clustered into epitope communities which map to various regions or faces of the spike protein when analyzed by cryo-EM,” said Bedinger. “Clones within these communities often share properties like neutralization and binding sensitivities to certain types of mutations.”
With a high-throughput approach, new antibodies can be rapidly binned into relevant communities and compared against the existing antibody population to understand their novelty and to predict their behavior.
Source: Visit Tampa Bay
As with many entrepreneurs, Founder and CEO Jorge Brea’s dreams took root in his childhood home. He started Symphonic Distribution in a spare bedroom of his parents’ house in 2006.
Symphonic helps independent artists and record labels get their music on streaming platforms and into the ears of listeners around the world.
In addition to being named to the Billboard magazine Indie Power Players list in 2018 and 2019, Brea has now grown his digital music services company to a team of over 50 passionate people in Tampa, Brooklyn, Denver, Nashville and Bogota, Colombia.
And while Brea’s vision and drive paved his way, Tampa Bay provided a supportive and thriving location in which to make his dreams a reality — and give them ample room to grow.
“I think Tampa is getting more creative and becoming a technology hub. It’s great to see new entrepreneurs and different types of business come into the area,” Brea says.
Ranked a best place to live
Tampa Bay’s quality of life earned it a spot on the 2019 U.S. News & World Report’s Best Places to Live list, and it was named a community where it’s cheaper to buy a home than to rent. Plus, Money magazine named Tampa Bay the Best Big City in the Southeast in 2015, and in 2018, WalletHub ranked Tampa Bay one of the top communities in Florida to start a business.
“Billions of dollars in public and private investment are transforming the way Tampa Bay works, lives and plays. Coming over the horizon, we have the building of new office space, major funding for tech incubators and loads of new options for urban living,” says Santiago C. Corrada, president and CEO of Visit Tampa Bay.
Millions in venture capital
“Tampa Bay combines a welcoming, small-town feel with the amenities of a major American city,” Corrada says. “It’s easy for newcomers to find their niche here. Tech startups, nonprofits, restaurants and entertainment — entrepreneurs from nearly every industry sector quickly discover that Tampa Bay residents reward creativity and vision with time and money — including millions in venture capital.”
Brea of Symphonic Distribution knows that firsthand. In 2017, equity firm Ballast Point Ventures put $4 million into the Tampa Bay-based firm, which also offers design, audio mastering, marketing, merchandising and licensing services. Brea says that funding has helped him hire senior staff the company needs to become increasingly competitive, and raise Symphonic’s profile even further, around the world.
“To say that we’re headquartered here and that we have global presence and global clients, including real superstars that are platinum artists, I think really does help shine a big light into what’s happening with Tampa and its development,” Brea says.
NEOGOV, a market leader in public sector human resources software, today announced a definitive agreement to merge with PowerDMS, a leader in cloud-based compliance software that helps customers simplify how they create, track, and attest to policies, training, and industry standards. The merger will expand NEOGOV’s product offerings and further demonstrates its commitment to streamlining the complex processes needed to support the public sector workforce. Terms of the transaction were not disclosed.
NEOGOV’s full suite human capital management solution enables recruiting, hiring, onboarding, training, performance management, payroll, benefits and time and attendance processes specific to public sector and higher education organizations. PowerDMS’ products strategically complement NEOGOV’s platform and capabilities, setting it up for the next chapter of the company’s growth. The merger will help customers solve complex human resource and compliance challenges under one roof by unifying best-in-class human resource tools and document management in an age of increased pressure for additional accountability and transparency.
The merger is subject to regulatory approval. The combined businesses will be operated by NEOGOV, which is headquartered in El Segundo, California. Shane Evangelist, current NEOGOV CEO, will be CEO of the combined company.
“The addition of PowerDMS to the NEOGOV family is a natural fit. It increases our core offering and deepens our expertise around procedure and policy management, which will ultimately enable us to modernize more of the vital systems that serve our citizens,” Evangelist said. “The tremendous team and solutions at PowerDMS furthers our mission to ‘Serve the people who serve the people.’ ”
PowerDMS offers a secure cloud-based policy, compliance, accreditation management solution that helps organizations with transparency, accountability, risk and liability reduction, increases organizational efficiency, and helps save lives. The company provides secure FBI CJIS compliant software tools to organize and manage an organization’s critical documents and industry accreditation standards and allows for training and testing of employees. PowerDMS serves customers in public safety, government, and healthcare and has achieved significant organic growth in these markets.
“Delivering transformative Cloud-based solutions that automate and scale complex processes needed to run local government is at the heart of what both companies do well. By expanding its offering to include the products of PowerDMS, NEOGOV is well-positioned to continue our success and further increase a combined footprint in the public sector,” said David DiGiacomo, CEO of PowerDMS.
The merger of PowerDMS broadens the solutions offered by NEOGOV and further supports the company’s long-term growth strategy and dedication to enhancing its comprehensive capabilities within the human resources software market.
William Blair served as exclusive financial advisor to PowerDMS in the transaction.
NEOGOV is the leading provider of an integrated HR, payroll, and talent management solution for the public sector. NEOGOV customers report increased employee productivity and engagement, time and cost savings, improved regulatory requirement compliance, and reduced paper processes, with a net result of better services for citizens. Serving over 6,000 organizations, NEOGOV provides intelligent HR for the public sector. More information at www.neogov.com.
Founded in 2001, PowerDMS offers a cloud-based compliance management platform that helps users reduce risk and liability, protect reputation, increase efficiency, and save lives. The company provides software tools to organize and manage an organization’s critical documents and industry accreditation standards and allows for training and testing of employees. Most of the over 4,000 PowerDMS customers represent high-risk industries with compliance requirements in the healthcare, government, and commercial sectors. To learn more, go to www.PowerDMS.com .
(Greenville, S.C) November 30, 2020 – Mailprotector, a Greenville, SC-based cybersecurity company, announced today that the U.S. Patent and Trademark Office recently issued U.S. Patent No.10708244 for Bracket®, a system and method for encryption, storage, and transmission of digital information.
The problem with traditional encryption methodologies is the complexity of the applications, implementation, and decoding processes. With Bracket, users simply wrap the subject line in brackets and hit send. The process for opening and decoding messages is equally effortless. Bracket features include:
- Messages encrypted using AES256 standards & geographically distributed key.
- Fool-proof sign-in mails with a secure, expiring link. No more lost passwords!
- Encrypted email can be sent from any email app on any device.
- MX-free for Office 365. No need to change records so they route through filtering services.
Bracket also includes an encrypted file transfer service, Bracket Share, which gives users a personalized file transfer page with an easy URL (share link) that they can provide to anyone. Shared files and messages show up in the Bracket inbox like a regular message. Other features include customizable links, personalized invitations, and sender validation.
“We are elated at the patent office’s acknowledgment of Bracket as a revolutionary encryption technology.” Says David Setzer, CEO of Mailprotector. “One of our core goals is to empower managed services providers with unique and highly valued services they can take to market. While our partners usually provide all the external validation we need, this patent confirms our commitment to technical innovation. Bracket gives MSPs a true advantage and differentiator in the security and encryption space, solves real end-user needs, and delivers highly profitable recurring revenue streams.”
Will Nobles, founder and CEO of IT services firm Vector Choice Technology Solutions, is leveraging Mailprotector’s encryption technology with a 1000 user healthcare provider, various attorneys, and other clients. “Innovations from our vendors, bringing new ideas like Bracket and Bracket Share, is invaluable to our business,” emphasizes Nobles. “With other systems, you have to install extensions in Outlook, and users have to follow multiple steps. Bracket is a lot easier to use, which means our clients are more apt to add the protection instead of sending email unencrypted.”
“Our design goal was to make security more accessible to users and our partners, not to create technology for technology’s sake,” adds Mailprotector’s CTO, Ben Hathaway. “That’s what makes Bracket special. The combination of ease of use with innovative and highly effective encryption. Our unique approach, detailed in the patent, allows us to offer users complete data privacy and security in a simple to use solution.”
Mailprotector empowers its users with a portfolio of cloud-based email security, management, and hosting services sold exclusively through the worldwide IT services channel. Products include inbound and outbound email security, email continuity, email archiving, email encryption, and business-class hosted email solutions. More information is available at www.mailprotector.com.
By: Alex Wilhelm
From a cluster of insurance marketplace startups raising capital earlier this year, to neoinsurance provider Lemonade going public this summer at a strong valuation, Hippo’s huge new round and Root’s impending unicorn IPO, 2020 has proven to be a busy year for startups and other growth-oriented private tech companies focused on insurance.
That news cycle continues today, with The Zebra announcing that it has reached a roughly $100 million run rate, and, perhaps even more notably, that it has turned profitable.
TechCrunch most recently covered the car and home insurance marketplace startup in February, when it raised the first $38.5 million in a Series C eventually worth $43.5 million that Accel led. As we noted at the time, the startup joined “Insurify ($23 million), Gabi ($27 million) and Policygenius ($100 million) in raising new capital this year.”
The Zebra released a number of financial performance metrics as part of its Series C cycle, including that it recorded revenues of $37 million in 2019, and that it had reached a $60 million annual run rate around the time of its Series C. The Zebra also said that it could double in size this year, putting it above a $100 million run rate by the end of 2020.
With that history in hand, let’s talk about the company’s more recent performance.
A changing market
According to the company, The Zebra recorded net revenue of $6 million in May, 2020. That number grew to around $8 million in September. For those of you able to multiply, $8 million times 12 is $96 million, or a hair under $100 million. According to a call with the The Zebra’s CEO Keith Melnick, the company’s September was very close to $8.3 million, a figure that would put it on a $100 million run rate.
Given that our $100 million ARR club has a history of granting startups a little wiggle room when it comes to their size, it seems perfectly fine to say that The Zebra has reached revenue scale of $100 million; at its current rate of growth, even if its final September revenue tally is a hair light. the company should reach a nine-figure topline pace in October.
According to Melnick, while the bulk of The Zebra’s revenue isn’t recurring, a growing portion of it is. Per the CEO, around 2-5% of The Zebra’s revenue was recurring last year, a figure that he said is up to around 10% today. (If The Zebra binds an insurance policy itself, and that policy is renewed, its commissions can recur.)
What drove the company’s quick 2020 growth? In part, the insurance market changed, with insurance networks that depended on in-person sales seeing their ability to drive business slow thanks to COVID-19. Insurance marketplaces like The Zebra stepped in to assist, helping move some offline demand online. Melnick detailed that dynamic to TechCrunch, adding that when certain advertising channels saw demand fall, his company was able to leverage inexpensive inventory.
A number of factors appear to have added to The Zebra’s rapid growth thus far in 2020. Our next question is whether other, related players in the insurtech startup space have seen similar acceleration. More on that in a few days.
Finally, regarding The Zebra, the company said that it is now profitable. Of course, profit is a squishy word in 2020, so we wanted to know precisely what the company meant by the statement. Per the company’s CEO, it is generating positive net income, the gold-standard for profitability as the metric is inclusive of all costs, including the non-cash expenses that startups tend to strip out of their numbers to make the results look better than they really are.
If other players in the insurtech space are surfing similar trajectories, all that capital that went into the sector around the start of the year is going to appear prescient.
TissueTech, Inc. Announces One-Year Follow-up Study Results – Cryopreserved Umbilical Cord allograft TTAX01
SOURCE Amniox Medical, Inc.
MIAMI, June 1, 2020 /PRNewswire/ — Amniox Medical Inc. (Amniox), a TissueTech, Inc. company and pioneer in the clinical application of human birth tissue-based products, announced today the results from the one-year follow-up study to their Phase 2 open label, multicenter pilot study of Cryopreserved Umbilical Cord allograft TTAX01. The objectives of the study were to examine the safety and efficacy of TTAX01, plus standard of care, in achieving complete wound closure of complex non-healing Diabetic Foot Ulcers (DFUs) with evidence of exposed bone, tendon, muscle and/or joint capsule and clinical suspicion of osteomyelitis. Results of this one-year study are published in the peer-reviewed journal Wound Repair and Regeneration.
The follow-up study indicates that TTAX01 is a promising adjunct therapy for the management of complex, non-healing DFUs complicated by osteomyelitis.1 The results of this one-year follow-up study with TTAX01 demonstrate an overall 86.2% wound closure rate and are comparable to previously reported results using the commercially available Cryopreserved Umbilical Cord NEOX® in a retrospective study.2 In that study by Caputo, 26 of 33 (79%) of the wounds achieved complete wound closure in 16 ±9.3 (range: 4–44) weeks with 1.2 ± 0.4 NEOX applications. The average wound size was 16 ± 18 cm.
“Although there have been numerous other studies published on the management of DFUs, the majority of these studies have been with less severe and more superficial Wagner Grades 1 and 2 DFUs – where there is no infection and little or no exposure of muscle, fascia, joint capsule, or bone. More severe and higher-grade Wagner 3 and 4 DFUs presenting with exposed bone and the presence of osteomyelitis are usually excluded in clinical trials as they are the most challenging wounds to manage,” said William A. Marston, MD, Vascular Surgeon at University of North Carolina at Chapel Hill and lead investigator for the Phase 2 trial. “We’ve chosen to go after the most severe DFUs to address a critical, unmet clinical need with the goal of identifying a successful treatment option to help this diabetic population exhibiting high morbidity and mortality. We are looking forward to the Phase 3 trials to be initiated soon, which will provide an opportunity to confirm these results in larger pivotal trials.”
There were 29 patients who participated in this follow-up study conducted at 11 U.S. healthcare facilities. An independent medical reviewer evaluated images to confirm each DFU closure as assessed by the principal investigator. Trial results showed that only an average of 1.5 applications were necessary to facilitate complete wound closure in 25 of the 29 total patients.
“The results of this Phase 2 study show not only higher than standard of care healing rates, but also fewer applications than studies using other amniotic membrane and similar wound care products for less severe wounds, which is ideal in today’s COVID-19 environment where we are doing all we can to reduce these high-risk patients’ exposure to a virus that could have dire consequences for their health,” said Amy Tseng, President and Chief Executive Officer of TissueTech. “I truly believe our strong scientific research background, combined with our willingness to look for clinical solutions for unmet needs in hard-to-heal patients is what distinctly differentiates TissueTech from other companies. The findings in the Phase 2 trial related to less frequent applications and persistent wound closure are of particular importance right now and offer new hope for a future treatment option in this vulnerable population where we see many wound care centers leveraging less frequent patient visits to the clinic to reduce risk as a result of the COVID-19 health crisis.”
About Amniox Medical, Inc.
Amniox Medical, Inc., a TissueTech, Inc. company, is a leader in the clinical application of human birth tissue-based products (amniotic membrane & umbilical cord) processed using TissueTech’s proprietary CRYOTEK® cryopreservation technology. Established in 2011, Amniox serves an unmet need for better surgical and therapeutic outcomes for chronic and complex wounds, orthopedics, sports medicine, spine, urology, gynecology, plastics, and general surgery. Connect with Amniox on our Website, Facebook, LinkedIn and Twitter.
About TissueTech, Inc.
TissueTech, Inc., the parent company of Amniox Medical, Inc. and Bio-Tissue, Inc., is a scientific and market leader in the field of regenerative medicine. TissueTech manufactures a broad range of ocular, surgical, wound care, and soft tissue products that are marketed under these subsidiaries. Since the company’s inception, clinicians have performed more than 500,000 human implants of the company’s products and published more than 360 peer-reviewed studies supporting its platform technology. TissueTech is committed to an unwavering culture of integrity that places our patients’ safety and clinical outcomes above all else. Learn more at https://tissuetech.com/.
- Marston, W. A., Lantis, J. C., Wu, S. C., Nouvong, A., Lee, T. D., McCoy, N. D., et al. (2019). An open-label trial of cryopreserved human umbilical cord in the treatment of complex diabetic foot ulcers complicated by osteomyelitis. Wound Repair Regen. 27, 680–686. doi: 10.1111/wrr.127542.
- Caputo, W. J., Vaquero, C., Monterosa, A., Monterosa, P., Johnson, E., Beggs, D., et al. (2016). A retrospective study of cryopreserved umbilical cord as an adjunctive therapy to promote the healing of chronic, complex foot ulcers with underlying osteomyelitis. Wound Repair Regen. Off. Publ. Wound Heal. Soc. Eur. Tissue Repair Soc. 24, 885–893.doi: 10.1111/wrr.12456
March 5, 2020 – Mailprotector, a Greenville, SC-based cybersecurity company, raised $5 million in growth equity funding from Ballast Point Ventures. The channel-centric company will use that capital to accelerate product development, grow sales and marketing efforts, and expand services to its strong and growing network of Managed Service Providers (MSPs). As part of the expansion, the company plans to add more than 30 positions across all departments at its Greenville, SC headquarters and other locations around the country.
The company has over a decade of experience providing highly available and highly secure email solutions to organizations around the world. As a cloud-based email security, compliance, encryption, and hosting platform, Mailprotector’s solution is engineered from the ground up with partners’ management needs as a top priority. Mailprotector puts a premium on user experience and security with its advanced product stack, including CloudFilter, SafeSend, SecureStore, XtraMail, CloudMail, Exchange+, and Bracket. The company’s patent-pending flagship email encryption product, Bracket, is as simple to use as it is secure.
“Mailprotector is dedicated to empowering our channel partners with highly valued services and profitable recurring revenue streams,” said David Setzer, Mailprotector founder & CEO. “We know that email is still the prime vector for cyber-attacks, especially financially crippling ransomware and phishing threats. This investment means we can supercharge the development of our world-class cybersecurity protection tools for our partners and their clients, giving them an even stronger first line of defense against cyber threats and user error,” Setzer added. “We were thrilled to find in Ballast Point a firm that aligns with our channel partner commitment and one who respects our stewardship responsibilities in those relationships.”
“We are excited to partner with David, CTO Ben Hathaway, and the entire Mailprotector team to drive continued email security leadership and technology innovation,” said Robert Faber, Partner at Ballast Point Ventures, who will join Mailprotector’s Board of Directors. “BPV has a long history of supporting high-growth software companies throughout the Southeast, and we have been impressed with David and his team as they have built industry-leading email security tools with limited outside capital investment.”
Mailprotector empowers its users with a portfolio of cloud-based email security, management, and hosting services sold exclusively through the channel to businesses, government, and non-profits around the world. Products include inbound and outbound email security, email continuity, email archiving, email encryption, and business-class hosted email solutions. More information is available at www.mailprotector.com.
About Ballast Point Ventures
Ballast Point Ventures, headquartered in Tampa, Florida, is a later-stage venture capital and growth equity fund founded in 2002 to provide expansion capital for rapidly growing, privately-owned companies, with a particular emphasis on companies located in Florida, the Southeast, and Texas. The BPV partners have more than 80 years of combined experience investing in and building high-growth companies in the firm’s target industries, including software, technology-enabled business services, and healthcare. Ballast Point Ventures has $360 million under management across three Funds and seeks to make initial equity investments ranging in size from $4 million to $10 million. For additional information, visit www.ballastpointventures.com.
Source: Intelligent Retinal Imaging Systems (IRIS)
PENSACOLA, Fla., Jan. 29, 2020 /PRNewswire/ — Intelligent Retinal Imaging Systems (IRIS), the industry leader in telemedicine solutions for diabetic retinal evaluation, was announced as a grantee for the Microsoft AI for Health Initiative. AI for Health, Microsoft’s newest initiative under their AI for Good program, will encompass a $40 million, 5-year program that will leverage AI to empower organizations like IRIS, and other companies in the realm of improving health.
“It has always troubled me when patients would come into my practice with severe late-stage eye damage and I couldn’t do anything to save their eyesight,” said Dr. Sunil Gupta, Retinal Surgeon and Founder at IRIS. “The opportunity to work with some of the most talented people in the world at Microsoft means that together we will generate new ideas and insights that will ultimately improve access to care, improve our ability to find and treat retinal disease earlier, all the while allowing us to more successfully save eyesight.” CEO of IRIS, Steve Martin added, “We are honored to have been chosen to partner with Microsoft through this great initiative. The exciting part about this opportunity is working with Microsoft to explore new technologies that will accelerate the development of AI solutions at IRIS to save people’s vision.”
Diabetic retinopathy is a leading cause of blindness across the world and 463 million people are currently at risk. Early detection and effective treatment can reduce the risk of blindness up to 95%. Microsoft’s collaboration with research and the development of an AI solution will empower IRIS to bring retinal evaluations to underserved populations across the globe in an effort to end preventable blindness. Through the AI for Health initiative, efforts will center on three key areas: Quest for Discovery, Global Health Insights, and Health Equity.
IRIS is one of six initial grantees for the AI for Health initiative and is honored to be recognized with organizations like BRAC, Fred Hutchinson Cancer Research Center, Novartis Foundation, PATH, and Seattle Children’s Research Institute. Each organization will work with Microsoft to use AI to decipher tough issues like discovering the cause of SIDS, eliminating leprosy, and building an ecosystem that allows safe and secure sharing of biomedical data.
The mission of the AI for Good program is to solve humanitarian issues and create a more sustainable and accessible world; this mission, combined with IRIS’ mission to eliminate preventable blindness shows a direct alignment and clearly demonstrates why this partnership will generate good for people.
About Intelligent Retinal Imaging Systems
Intelligent Retinal Imaging Systems (IRIS) is a Pensacola, Fla.-based company founded in 2011, with a vision to end preventable blindness through the development and deployment of retinal diagnostic services. The company’s IRIS solution includes an FDA Class II cleared medical device that has improved quality, expanded access and reduced costs for diabetic retinopathy exams across the U.S. For additional information visit our website: www.retinalscreenings.com
Microsoft (@microsoft) is the leading platform and productivity company for the mobile-first, cloud-first world, and its mission is to empower every person and every organization on the planet to achieve more.