Compulink Partners with Promptly to Provide Cutting Edge Patient Engagement
Company adds full suite of mobile patient engagement tools to its all-in-one EHR solution
Newbury Park, CA – Compulink Healthcare
Solutions, a leader in specialty specific all-in-one EHR solutions, has announced its partnership with Promptly, provider of the leading comprehensive web-based patient experience suite on the market, to deliver new mobile-friendly patient engagement tools for its Advantage SMART Practice® solution.
Dubbed Advantage Patient Experience™, this suite is comprised of easy-to-use features providing patients with the latest in mobile device convenience, while simultaneously reducing the administrative burden on office staff.
Some of the features of Advantage Patient Experience include:
- Smart online scheduling allowing patients to self-schedule with real-time availability using a simple Q&A for selecting the correct appointment type.
- Automated Waitlist functionality which reaches out to patients automatically when the system detects a cancellation on a provider’s schedule.
- Patient kiosk accessible from mobile phone or in-office tablet for easy update of patient information, scanning of driver’s license/ insurance card, e-sign of consents, and friction-less payment. Kiosk supports over 100 languages.
- Mobile check-in feature with geo-location services that automatically checks patient in when they arrive at the office and alerts patients to drive times to the office.
- Multi-level patient messaging via text, email, or interactive voice response.
- Text-to-pay supporting virtual wallets.
- Patient cost estimator using real-time data to provide patients with price transparency and accelerate collections while satisfying the No Surprises Act.
- Fully automated vision insurance eligibility for Ophthalmic businesses.
“We believe this suite of state-of-the-art patient engagement tools will allow our clients to provide more personalized care to their patients at a substantially lower cost to the practice”, said Link Wilson, CEO and Product Architect. “Self-serve features like online scheduling and balance alerts with text-to-pay not only provides added convenience for patients but helps improve cashflow and bottom line business profitability.”
Compulink’s Advantage SMART Practice, all-in-one database solution includes a specialtyspecific EHR, practice management, inventory management, patient engagement, ASC, E-commerce, and Optical POS (for ophthalmic practices). The company also provides an expert revenue cycle management service for its clients. Advantage is 2015 ONC Certified for MIPS. Compulink is used by more than 25,000 providers in over 4,900 locations, 70 ASCs, and 19 universities and colleges.
“We are extremely excited about this partnership with Compulink. Adding our patient experience suite to their comprehensive solution gives these organizations all the tools they need to automate their practices,” said Dr. Anish Kapur, President of Promptly. “The feedback we have gotten from our mutual clients has been fantastic. When our two systems are implemented at a practice, they work harmoniously to alleviate staff shortages and stresses while eliminating tedious front office tasks, increasing revenue, and improving patient satisfaction.”
About Compulink Healthcare Solutions
A leader in specialty specific EHR and Practice Management for 37 years, our all-in-one solution enables today’s private practice to deliver personalized patient care more efficiently for better outcomes and financial performance. With more smart features to automate patient flow and speed documentation, Compulink offers the industry’s only EHR solution that adapts to your workflow.
About Promptly LLC
Promptly is a comprehensive web-based patient experience and automation suite designed for medical practices to enhance patient touchpoints, accelerate patient payments and automate processes to support your team while combating staffing shortages.
Find out more at: PromptlyCheckIn.com
PHATHOM PHARMACEUTICALS SUBMITS
Vonoprazan Nda to Fda for the Treatment of Erosive Esophagitis
FLORHAM PARK, N.J., March 14, 2022 –
Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of vonoprazan as a treatment for adults for the healing of all grades of erosive esophagitis (EE) and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn. Erosive esophagitis, a major type of gastroesophageal reflux disease (GERD), affects approximately 20 million people in the U.S. In addition to experiencing troubling heartburn symptoms, patients with inadequately treated EE
may progress to more severe diseases including Barrett’s esophagus, a condition in which esophageal tissue changes can progress to cancer.
“The submission of this NDA is another exciting step towards bringing the first major innovation to the U.S. GERD market in over 30 years,” said Azmi Nabulsi, M.D., Chief Operating Officer at Phathom. “Proton pump inhibitors (PPIs) are currently the standard of care for EE yet approximately half of all U.S. patients progress their lines of therapy annually. We believe there is great interest among patients and healthcare providers for new treatment options to address the shortcomings of current treatment. If approved, vonoprazan has the potential to satisfy the large unmet needs of millions of patients and set a new treatment paradigm in EE.”
This NDA is based on the positive data previously announced from Phathom’s pivotal Phase 3 PHALCON-EE trial, a randomized, doubleblind, multicenter trial that enrolled 1,024 patients with EE in the U.S. and Europe and compared vonoprazan to lansoprazole, a standard of care PPI, in the healing and maintenance of healing of
EE, and heartburn symptom relief. PHALCONEE successfully met its primary endpoints and key secondary superiority endpoints.
About Erosive Esophagitis
Erosive esophagitis is a condition characterized by the presence of breaks, or erosions, in the esophageal tissue caused by constant irritation of the mucosal surface and subsequent loss of defense mechanisms against acid and digestive enzymes. Chronic erosive esophagitis can lead to complications including peptic stricture, a narrowing of the esophagus that causes difficulty swallowing, and Barrett’s esophagus, a condition in which esophageal tissue changes can progress to cancer. Uncontrolled reflux disease can also result in extra-esophageal diseases such as respiratory problems, chest pain, angina, and increased mortality.
About PHALCON-EE
PHALCON-EE was a randomized, double-blind, two-phase, multicenter, Phase 3 trial that enrolled 1,024 patients with EE in the U.S. and Europe. The first phase of the trial evaluated the efficacy and safety of vonoprazan 20 mg administered oncedaily (QD) compared to lansoprazole 30 mg QD for the healing of EE for up to eight weeks. The second phase of the trial evaluated the efficacy and safety of vonoprazan 10 mg QD and 20 mg QD compared to lansoprazole 15 mg QD for the maintenance of healing of EE for 24 weeks. Both phases also evaluated heartburn symptoms.
About Vonoprazan
Vonoprazan is an investigational, oral small molecule potassium-competitive acid blocker (P-CAB). P-CABs are a novel class of medicines that block acid secretion in the stomach. Vonoprazan has shown the potential to have rapid, potent, and durable anti-secretory effects as a single agent in the treatment of gastroesophageal reflux disease (GERD) and in combination with antibiotics for the treatment of Helicobacter pylori (H. pylori) infection. The FDA has awarded qualified infection disease product (QIDP) status and granted Fast Track designation to vonoprazan in combination with both amoxicillin and clarithromycin and with amoxicillin alone for the treatment of H. pylori infection. Phathom in-licensed the U.S., European, and Canadian rights to vonoprazan from Takeda, which completed 19 Phase 3 trials for vonoprazan and received marketing approval in Japan and numerous other countries in Asia and Latin America.
About Phathom
Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a novel potassium competitive acid blocker (P-CAB) in late-stage development for the treatment of acidrelated disorders. For more information about Phathom, visit the Company’s website at www. phathompharma.com and follow the Company on LinkedIn and Twitter.
Forward Looking Statements
The Company cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Company’s business, including, without limitation: we may not obtain regulatory approval of our NDAs for the treatment of H. pylori, erosive esophagitis, or the other indications in which we are developing vonoprazan; even if we receive regulatory approval, the Company may experience delays in its plans to commercially launch vonoprazan in particular as we currently have a limited marketing and no sales organization and have no experience as a company in commercializing products; the Company may experience delays in designing and initiating a Phase 3 on-demand study in NERD, including in the event that the FDA does not agree with the Company’s study design or its interpretation of the data; the Company will require substantial additional financing to achieve its goals and may not be able to obtain such financing on acceptable terms, or at all; the Company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/ or commercialization, or may result in recalls or product liability claims; previously granted QIDP and Fast Track designations may be withdrawn or not actually lead to a faster development or regulatory review or extended exclusivity, and would not assure FDA approval of vonoprazan; the Company’s ability to obtain and maintain intellectual property protection for vonoprazan; the Company’s ability to comply with its license agreement with Takeda; the Company’s ability to maintain undisrupted business operations due to the ongoing presence of the COVID-19 coronavirus, including delaying or otherwise disrupting its clinical trials, manufacturing and supply chain, and other risks described in the Company’s prior filings with the Securities and Exchange Commission (“SEC”), including under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Evoendo Announces Us Fda 510(K) Clearance for Single-use Unsedated Transnasal Endoscopy (Tne) System
EvoEndo’s Single-Use Endoscopy System or the “EvoEndo System” eliminates the need for general anesthesia or conscious sedation during routine upper endoscopic procedures • The EvoEndo System is being distributed by Micro-Tech Endoscopy USA with commercial sales slated to begin following completion of first clinical cases at several pediatric facilities
DENVER, CO – EvoEndo®, Inc. (“EvoEndo”), a medical device company developing systems for Unsedated Transnasal Endoscopy (TNE), has announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) to begin marketing and sale of the EvoEndo® SingleUse Endoscopy System. The clearance follows EvoEndo’s distribution agreement with MicroTech Endoscopy USA, Inc. (“Micro-Tech”), which will begin a phased distribution of the EvoEndo System into hospitals and ASCs in the United States.
EvoEndo was founded in 2017 by Dr. Joel Friedlander, a Pediatric Gastroenterologist at Children’s Hospital of Colorado, and is led by Chief Executive Officer Dr. Heather Underwood, an experienced medical device and technology entrepreneur, and alumna of the Stanford University Biodesign Program. While traditional endoscopy requires patients to undergo general anesthesia or sedation, the EvoEndo System combines sterile, single-use, flexible endoscopes, a portable video controller, and a take-home “comfort kit” containing virtual reality (VR) goggles for patient entertainment and distraction during the procedure to allow for unsedated transnasal endoscopy. The EvoEndo System ultimately enables safer and more cost-effective upper endoscopic procedures for patients, doctors, and hospitals. The FDA clearance is the latest milestone for EvoEndo, who also announced the completion of a $10.1M equity financing round last June.
Heather Underwood, Chief Executive Officer at EvoEndo, commented, “Receiving FDA 510(k) clearance for the EvoEndo System will allow us to execute on our mission of enabling a safer, faster, and more affordable alternative to sedated endoscopy for both pediatric and adult patients. This is an exceptional accomplishment for our team and validates our ongoing commitment to transform best practices in endoscopy and support the broader adoption of unsedated procedures throughout the U.S.” “With today’s announcement, we are one step closer towards making unsedated endoscopies the standard of care within the medical community,” said Joel Friedlander, Chief Medical Officer and Co-Founder of EvoEndo. “We are thrilled to receive this clearance and proud to be on the forefront of a new and innovative system to help diagnose and treat pediatric and adult patients.”
“The EvoEndo® Model LE Single-Use
Gastroscope addresses critical clinical needs in current pediatric and adult endoscopy practice and is a prime example of the innovative medical technology we strive to provide to our network,” stated Micro-Tech USA President Chris Li. “A combination of the smaller scope size, larger biopsy channel, coupled with a sterile single-use device can help save valuable procedure time and cost. We look forward to further growing our partnership with EvoEndo and to the successful completion of initial clinical cases.”
The EvoEndo System is only intended for use by medical professionals. Physicians and other medical providers interested in learning more about EvoEndo’s TNE system or to schedule demonstrations and training can contact the company here.
About EvoEndo®
EvoEndo®, Inc. is a medical device company developing systems that enable unsedated endoscopic procedures through a combination of sterile single-use, flexible endoscopes and VRbased patient distraction. EvoEndo’s technology allows pediatric patients and adults alike to receive routine endoscopies in a clinic setting without the use of general anesthesia or sedation, while reducing complexity, cost, and patient/provider apprehension.
To learn more, please visit: evoendo.com/
About Micro-Tech Endoscopy USA
Since 2000, Micro-Tech Endoscopy has been focused on creating top-quality products for endoscopic diagnosis, and therapeutic medical devices that allow physicians to provide the highest level of care. By partnering with doctors dedicated to innovation, Micro-Tech is committed to bringing better devices to market, with unparalleled speed, at an economical price, and without the burden of contracts. Micro-Tech does not compromise on quality and does not believe customers should either.
Micro-Tech Endoscopy has operations in America, Asia, and Europe and leverages this global reach to rapidly commercialize and refine the products it brings to its clinician partners. Micro-Tech’s team has a wealth of experience in the field and in-depth understanding of both product and use cases.
With the health care industry transforming rapidly, Micro-Tech Endoscopy is dedicated to setting the pace as a disruptor. Micro-Tech is more than a medical technology company, it is building a community of healthcare innovators and making health care more value-driven.
Smart Medical Systems’ G-eye® Colonoscope Is Now Fda Cleared on Olympus’ Pcf Colonoscope Series, Making It Available in the United States on the Commonly Used Models of All Leading Endoscopy Brands Fda has approved the use of G-EYE® with Olympus’ 510(k) cleared PCF colonoscopes
RA’ANANA, Israel, – SMART Medical Systems Ltd., a developer and manufacturer of innovative endoscopy products, announced an additional FDA clearance for its G-EYE® Colonoscope, based on Olympus’ 510(k) cleared PCF colonoscope series. With this additional FDA clearance, G-EYE® is now available for use in the U.S. market on the commonly used colonoscope models of all three leading endoscopy brands – OLYMPUS, FUJIFILM, and PENTAX Medical.
“The ability to offer G-EYE® on colonoscope brands and models commonly used and widely available in the United States is an important milestone for SMART Medical, patients, and endoscopists,” said Gadi Terliuc, Chief Executive Officer of SMART Medical. “The majority of U.S. endoscopists now have the option to utilize our cutting-edge technology, which has been shown in clinical studies to improve visualization compared with standard colonoscopy, while using their preferred brand and model of colonoscope. We are very excited to have completed our portfolio of U.S. G-EYE® offerings and believe that the widespread availability of the technology on the commonly used colonoscope models has the potential to accelerate adoption of G-EYE® colonoscopy as the standard of care.”
The G-EYE® Colonoscope is a 510(k) cleared colonoscope, remanufactured by SMART to include a proprietary balloon at its distal bending section. Withdrawal of the G-EYE® Colonoscope with the balloon moderately inflated during colonoscopy assists in controlling the colonoscope’s field of view and positioning. A published study (GIE 2019; 89: 545-53) demonstrated that G-EYE® can improve colonoscopy outcomes compared with standard colonoscopy across several metrics, including increasing adenoma detection rate (ADR) by 28%, detecting 47% more adenomas per patient (APP), 62% more advanced and large adenomas, and 142% more flat adenomas.
“We expect that this FDA clearance of the G-EYE® Colonoscope based on Olympus’ PCF scopes, which many Olympus users prefer over traditional adult-sized colonoscopes, will enhance our ability to capture a substantial portion of the U.S. colonoscopy market,” said Brian Cochrane, Chief Commercial Officer of SMART’s U.S. subsidiary. “We are committed to becoming the standard of care in colonoscopy, and this FDA clearance is an important step toward achieving this critical goal.”
About SMART Medical Systems
SMART Medical Systems is a pioneer in the development and manufacture of innovative medical devices in the field of gastro-intestinal (GI) endoscopy. SMART’s unique approach is to address key challenges in contemporary endoscopy while using available brand name endoscopes. SMART’s CE Marked and FDAcleared NaviAid™ and G-EYE® product families are commercially distributed in key global markets. With its partnership with FUJIFILM and PENTAX Medical, SMART’s G-EYE® colonoscopy solution is currently adopted by two of the three industry leaders in GI endoscopy imaging. SMART is headquartered in Israel, and operates in the United States through its wholly-owned subsidiary, SMART GI Inc.
For more information, please visit: smartmedsys.com/us/