BESANCON, France–(BUSINESS WIRE)– Pixee Medical, a pioneer in digitally augmented surgery technology, announces that its Knee+ AR computer assisted orthopedic solution has received 510(k) clearance from the U.S. Food and Drug Administration.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210428005803/en/
(Photo: Pixee Medical)
Knee+ is a patented platform designed to assist orthopedic surgeons to perform surgeries better and faster by providing real-time positioning of instruments, right in their field of view. Knee+ is intuitive and requires minimal training since it does not change the overall technique for 90% of surgeons who use a conventional technique but have never utilized navigation or robots. Knee+ consists in a proprietary software using unique computer vision and artificial intelligence algorithms and running on connected smartglasses, with no bulky capital equipment or disposables required.
Video Link: https://bit.ly/3dPKfcf
The first Knee+ surgery was performed in June 2020 in Lariboisière Hospital in Paris. Pixee Medical began commercialization in Europe and Australia in January 2021 and was surprised by just how quickly its product was adopted, with more than 60 systems sold in Q1. The company proved that the market was ready for this innovation and is now expanding rapidly by partnering with leading orthopedic implant companies.
“The FDA’s clearance of Knee+ is an important step forward as the USA represents 50% of the worldwide market. We plan to quickly expand our platform to perform hip and shoulder replacements” states Sébastien Henry, Founder and CEO of Pixee Medical. “In addition, our platform is designed to become the cornerstone of data acquisition and exchange during surgery as well as a plug-and-play hub for accessories like connected instruments, robotic arms and wireless tools.”
“Today, Knee+ is well positioned to help ambulatory surgical centers face the significant backlog and increase in knee surgery. These centers need intuitive, effective, attractive and affordable solutions to meet their patients’ needs, now.”
About Pixee Medical
Pixee Medical’s ambition is to empower all orthopedic surgeons with the latest breakthrough in precision surgery, to become digitally augmented surgeons. Learning from the success, as well as the challenges of adopting navigation and robotized approaches, Pixee Medical developed its surgeon-centric platform with the belief that all surgeons deserve intuitive tools to augment their knee, hip and shoulder replacement surgeries, without facing hurdles in terms of capital equipment, changing techniques, training, additional staff or longer procedure times. Pixee Medical’s augmented surgery platform is commercially available in Europe, Australia, and the USA for total knee arthroplasty with Knee+.
AbbVie Subsidiary Scoops Up Soliton and Its Cellulite, Tattoo Removal Device
© AbbVie Inc. All rights reserved.
AbbVie‘s Allergan Aesthetics’ most well-known brands right now include BOTOX and CoolSculpting, among others. However, with the company’s latest acquisition, another one might slide its way to the top.
On Monday, Allergan Aesthetics announced that it is acquiring Soliton in a definitive agreement that is valued at approximately $550 million. Allergan Aesthetics will pay $22.60 per share for each outstanding Soliton share.
Perhaps the most notable gain from the deal is the acquisition of Soliton’s RESONIC, the company’s novel platform technology that uses non-invasive, high-frequency sound waves to disrupt targeted cellular structures and connective tissue.
The technology has received U.S. Food and Drug Administration (FDA) 510(k) clearance for short-term improvement and appearance of cellulite and for use in conjunction with a laser for tattoo removal.
“There is a huge unmet need to address cellulite and effective treatments have been elusive and frustrating for consumers,” said Carrie Strom, President, Global Allergan Aesthetics and Senior Vice President, AbbVie. “Soliton’s technology offers a new, completely non-invasive approach with clinically-proven results to reduce the appearance of cellulite with no patient downtime.”
Just last week, Soliton announced the rollout of RESONIC, its Rapid Acoustic Pulse (RAP) device. The company boasted that the technology “helps achieve 75% greater fading of tattoos in as few as 3 sessions and improves the appearance of cellulite non-invasively,” according to the announcement.
“RESONIC revolutionizes the industry’s approach to two notoriously challenging patient needs. The technology’s ability to physically change targeted cellular structures without breaking the skin is game changing,” said Dr. Elizabeth Tanzi, board certified dermatologist and member of Soliton’s scientific advisory board, at the time of the announcement.
Allergan Aesthetics is still a fairly new face in the industry. In the midst of AbbVie finalizing its $63 billion merger with Allergan, early last year the company announced plans for Allergan Aesthetics, a stand-alone company tasked with continuing to build out AbbVie’s aesthetics programs.
RESONIC received its first FDA clearance in 2019, but is not expected to roll out until June 2021 in medically supervised spas and through a select network of physicians.
“This is an exciting day for Soliton and the RESONIC brand,” said Brad Hauser, president and CEO of Soliton, at the time of the announcement. “It’s been a long time in the making and we’re excited to finally bring this innovative and efficacious solution to procedures that have had historically low patient satisfaction or required numerous treatment sessions to achieve expected results. Launching RESONIC with two unique indications has been a strategic goal of ours since receiving our first FDA clearance in 2019.”
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Sequana Medical Announces Strong Top-Line Results from RED DESERT alfapump DSR® Study and Expansion of DSR® Development Programme
- RED DESERT data of all patients confirm:
- alfapump DSR is highly effective at managing fluid and sodium balance in diuretic-resistant heart failure patients without need for loop diuretics
- restoration of diuretic response and improvement in cardio-renal function
- improvement in diuretic response maintained in long-term follow-up
- SAHARA DESERT study in heart failure patients with residual congestion to start in Q2 2021
- Expanding DSR development programme with short-term DSR therapy
- Evaluating opportunity for DSR therapy for fluid and sodium removal in renal disease
Conference call with live webcast today at 15:00 CEST / 09:00 am EDT
GHENT, Belgium, May 11, 2021 (GLOBE NEWSWIRE) — Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces positive top-line results from the RED DESERT study with repeated dose alfapump DSR® (Direct Sodium Removal) therapy in diuretic-resistant heart failure patients.
SAHARA DESERT, the study of the alfapump DSR in diuretic-resistant heart failure patients with residual congestion is on track to start before the end of this quarter, with interim results expected before year-end and top-line results expected in H2 2022.
In addition, Sequana Medical announces that it will expand its DSR development program with the addition of short-term DSR therapy. Short-term DSR is expected to achieve faster adoption of DSR therapy by the clinical community, support alfapump DSR market entry, expand the potential market opportunity and target earlier entry into the U.S. market. MOJAVE DESERT, the first U.S. feasibility study of short-term DSR therapy, is planned to start in H2 2022. Based on FDA feedback, SONORAN DESERT, the U.S. efficacy study of alfapump DSR therapy, is now planned to commence in mid-2023 to allow completion of long-term pre-clinical studies.
Fluid and sodium overload is an important clinical problem in renal disease / hemodialysis and Sequana Medical is evaluating the opportunity for DSR therapy to improve clinical outcomes and is supporting the clinical work of Dr. McIntyre of Lawson Health Research Institute, Ontario, Canada.
Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: “These RED DESERT results are very exciting and further confirm the potential clinical benefits of our alfapump DSR therapy. Repeated alfapump DSR therapy not only managed the fluid and sodium balance throughout the study without the need of any loop diuretics but crucially it also restored patients’ diuretic response and overall cardio-renal status. We are very encouraged by the durability of the reduction in loop diuretics and believe our novel alfapump DSR therapy has the potential to transform the treatment of this large and growing patient group.
“In light of the success of RED DESERT, we have concluded the study at eight patients so that we can move on to the SAHARA DESERT study as soon as possible, where we will be treating our anticipated patient population.
“We are expanding our DSR development programme into short-term DSR treatment, complementing our long-term alfapump DSR treatment. We believe that short-term DSR therapy plays a crucial role in establishing this breakthrough treatment and enhances the market opportunity for alfapump DSR therapy. This combined strategy of short-term and long-term DSR therapy will reinforce our leadership role in addressing diuretic-resistant fluid overload.”
Strong top-line results from RED DESERT
Eight patients diagnosed with stable chronic heart failure on high dose oral diuretics (mean furosemide equivalent dose of 323 mg/day) were implanted with the alfapump DSR system and underwent up to six weeks of DSR therapy whilst their loop diuretic treatment was withheld. The heart failure patients enrolled in the study had an overall high disease severity at baseline, including a mean left ventricular ejection fraction of 24% and mean NT-proBNP of 4,589 pg/mL.
During the course of the six-week therapy, none of the patients required any loop diuretics, demonstrating the ability of repeated alfapump DSR therapy to effectively manage their fluid and sodium balance. After the six-week study, the mean response to a standard diuretic challenge (40 mg intravenous furosemide) improved by more than 250% (p<0.001 vs baseline, N=7) as measured by the six-hour excretion of sodium. This improvement of diuretic efficiency was maintained with a 79% reduction of average loop diuretic dose at a median of 10 months post-study versus baseline and all patients were receiving less than or equal to 50% of their baseline diuretic dose (maximum follow-up post-study is 12.5 months).
The results clearly show a significant benefit to the cardio-renal function of these patients with a mean 30% reduction in NT-proBNP (p<0.001 vs baseline, N=7), mean 22% improvement in estimated glomerular filtration rate (p<0.001 vs baseline, N=7) and mean 22% reduction in creatinine (p<0.001 vs baseline, N=7). Typically, managing the fluid balance in these patients through aggressive diuretic use would be associated with declining cardio-renal function, whilst RED DESERT showed that both of these functions were improved following repeated alfapump DSR therapy.
In all patients, there were no clinically relevant changes in serum sodium levels or progressive hyponatremia. There were two serious adverse events in two of the last three patients, both having advanced heart failure. There was one transient ischemic attack (fully recovered) and one sudden cardiac death. The Data Monitoring Committee (DMC) assessed both events as possibly related to the study therapy or procedure but unlikely to be related to the device. The site Principal Investigator assessed that neither event was related to the study therapy, procedure or device.
Dr. Jozef Bartunek, Interventional Cardiologist at Onze-Lieve-Vrouw Hospital in Aalst (Belgium) and Principal Investigator of the RED DESERT study, commented: “These results confirm that alfapump DSR therapy is well tolerated and manages to quickly maintain a neutral sodium balance and stable body weight over six weeks, despite complete withdrawal of loop diuretics. The substantial improvement in diuretic response together with the meaningful improvement in NT-proBNP and renal function could be a potential game-changer.”
Dr. Jeffrey Testani, Associate Professor at Yale University and Heart Failure Scientific Advisor of Sequana Medical, added: “There is a significant need for novel therapies for sodium and fluid removal in heart failure, given the toxicity of loop diuretics and the high prevalence of resistance to these agents. The simultaneous normalisation of diuretic response and improvement in cardio-renal status of the RED DESERT patients is a never before seen treatment effect and could translate into important long-term clinical benefits in heart failure patients. I am looking forward to further clinical research to better understand the cardio-renal benefits of alfapump DSR therapy and its application to heart failure patients in urgent need of improved treatment options.”
SAHARA DESERT on track to start before end Q2 2021 – Interim results end 2021, Top-line results H2 2022
The SAHARA DESERT study will build on the learnings from RED DESERT and moves into sicker heart failure patients – those with residual congestion and for whom oral diuretics are no longer effective at preventing fluid overload. The study in 20 patients will evaluate the treatment algorithm and the ability of alfapump DSR therapy to eliminate the residual congestion and restore the correct fluid status (euvolemia) for up to 22 weeks. Interim results are expected before end 2021 with top-line results planned for H2 2022.
Expanding DSR development programme with short-term as well as long-term DSR therapy
As a result of the positive results from RED DESERT, the DSR development programme is being expanded into short-term DSR therapy to complement long-term alfapump DSR therapy. The intention is to enable faster adoption of DSR therapy by the clinical community by reducing barriers to adoption, support alfapump DSR market entry, expand the potential market opportunity and target earlier entry into the U.S. market.
A key element of the DSR programme is the development of DSR Infusate 2.0, Sequana Medical’s proprietary DSR Infusate. The intention is to deliver an infusate with a superior therapeutic profile as well as a high margin recurring revenue flow to accompany alfapump sales. Pre-clinical development work on DSR Infusate 2.0 is ongoing and preparations are being made for Chemistry, Manufacturing and Controls (CMC) activities.
Short-term DSR therapy will involve repeated DSR treatment for approximately 2 weeks, using DSR Infusate 2.0 in combination with a peritoneal catheter (instead of the alfapump). MOJAVE DESERT, the U.S. proof-of-concept study of short-term DSR therapy is scheduled to start in H2 2022. The study design will leverage the learnings from SAHARA DESERT as well as the anticipated superior therapeutic profile of DSR Infusate 2.0. The use of short-term DSR therapy without the alfapump has been enabled by the fundamental DSR patents that have been granted in the U.S. and Europe, and are under review elsewhere in the world.
Following discussions with the FDA, SONORAN DESERT, the U.S. controlled efficacy study of alfapump DSR is now planned to commence in mid-2023 to enable completion of long-term pre-clinical studies prior to study commencement.
Evaluating opportunity for DSR therapy in fluid and sodium overload in renal disease / hemodialysis
The effective management of fluid and sodium overload is a significant problem in renal disease / hemodialysis. Sequana Medical is evaluating the opportunity for DSR therapy to address this poorly met clinical need and is supporting the work of Dr. Chris McIntyre of the Lawson Health Research Institute, Ontario, Canada who is evaluating the use of DSR therapy in effective volume management and sodium removal in prevalent hemodialysis patients (ClinicalTrials.gov NCT04603014). Results of this work will be shared in due course.
|Conference Call and Webcast
Sequana Medical will host a conference call with live webcast presentation today at 15:00 CEST / 09:00 EDT.
The webcast and conference call will be conducted in English and a replay will be available on Sequana Medical’s website shortly after.
For more information, please contact:
Director Investor Relations
Tel: +32 498 05 35 79
Guillaume van Renterghem
Tel: +41 76 735 01 31
About RED DESERT study design
RED DESERT is a prospective, single-arm, first-in-human study to evaluate the safety and feasibility of alfapump DSR. Eight patients diagnosed with stable chronic heart failure on high doses of oral diuretics were implanted with the alfapump DSR system (alfapump and implanted surgical port). Following implantation, patients underwent a standardised diuretic challenge (40 mg intravenous furosemide) to quantify their response to diuretics, and this was repeated at specific time points throughout the study. At the start of the study treatment, patients were admitted for a 14-day in-patient period in which diuretics were withheld and patients were treated with DSR D10% infusate on Monday, Wednesday and Friday. Following the 14-day in-patient period, diuretics continued to be withheld and patients came into the clinic for their DSR treatment over the subsequent four weeks.
The primary safety endpoints include rate of device, procedure and/or therapy related serious adverse events through day 14 and through day 42. Secondary feasibility endpoints include the ability of alfapump DSR to maintain a neutral sodium balance in the absence of diuretic treatment and the sustained effect of DSR to maintain euvolemia through week six. Additional exploratory endpoints include the potential impact of DSR to restore response to diuretics following DSR treatment. For more information about the study, please visit clinicaltrials.gov (NCT04116034).
About Sequana Medical
Sequana Medical is a commercial stage medical device company utilizing its proprietary alfapump® and DSR® (Direct Sodium Removal) technologies to develop innovative treatments for fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a frequent complication of many large diseases including advanced liver disease driven by NASH (non-alcoholic steatohepatitis)-related cirrhosis and heart failure, with diuretic resistance being widespread. The U.S. market for the alfapump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for DSR and the alfapump DSR® is estimated to be over €5 billion annually in the U.S. and EU5 by 2026.
The alfapump is a unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination. DSR is Sequana Medical’s proprietary approach to managing sodium and fluid overload through use of a sodium-free infusate administered into the abdominal cavity.
In the U.S., the Company’s key growth market, the alfapump has been granted breakthrough device designation by the FDA for recurrent or refractory ascites due to liver cirrhosis. Interim data from the ongoing North American pivotal study (POSEIDON) showed positive outcomes against all primary endpoints of the study. This study is intended to support a future marketing application of the alfapump in the U.S. and Canada. In Europe, the alfapump is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites and is included in key clinical practice guidelines. Over 850 alfapump systems have been implanted to date.
Sequana Medical has combined its proven alfapump and proprietary DSR therapy, and is developing the alfapump DSR, a breakthrough approach to fluid overload due to heart failure. RED DESERT, the repeated dose alfapump DSR study in diuretic-resistant heart failure patients has demonstrated that repeated DSR therapy is able to both manage the fluid and sodium balance of these patients as well as restore their diuretic response and cardio-renal status.
Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.
Important Regulatory Disclaimers
The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com. The DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. The DSR® therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.
Note:alfapump® is a registered trademark. DSR® and alfapump DSR® are registered trademarks in the Benelux.
This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.
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IRRAS Announces Notified Body Transition from GMED to DEKRA, a Global Leader in Inspection and Certifications
STOCKHOLM, May 11, 2021 /PRNewswire/ — IRRAS AB, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, announced today that the CE Mark certificates for its IRRAflow system and the company’s ISO13485:2016 certification have been transferred to a new notified body, DEKRA. After the successful completion of a recent audit by DEKRA, these CE Mark certificates for IRRAflow will remain valid until May 2024.
“With DEKRA, we are building a relationship with one of the largest, most respected notified bodies in the world,” said Will Martin, President and Chief Commercial Officer of IRRAS. “DEKRA has resources in place near our US headquarters in Southern California, so important regulatory work has continued despite Covid-19. We believe that this transition can shorten our approval timelines and allow us to consistently plan our European product introductions moving forward.”
“Consolidating our regulatory relationships with DEKRA, a global leader in the space, as our notified body is an important step in the long-term growth of IRRAS,” said Kleanthis G. Xanthopoulos, PhD., Chief Executive Officer of IRRAS. “Regulatory requirements have changed dramatically in Europe, and, as guidelines evolve, it is critical that we take needed steps to ensure that our life-saving products remain available to patients in Europe.”
Founded more than 95 years ago, DEKRA is the leading expert organization and largest notified body in Europe. DEKRA is one of the five largest notified bodies globally and was also one of the first notified bodies to be approved under Europe’s new Medical Device Regulations. The company currently employs more than 43,000 people in approximately 60 countries on six continents.
IRRAS is a global medical care company focused on delivering innovative medical solutions to improve the lives of critically ill patients. IRRAS designs, develops, and commercializes neurocritical care products that transform patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methodologies. IRRAS markets and sells its comprehensive, innovative IRRAflow and Hummingbird ICP Monitoring product lines to hospitals worldwide through its direct sales organization in the United States and select European countries as well as an international network of distribution partners.
IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in Munich, Germany, and San Diego, California, USA. For more information, please visit www.irras.com.
IRRAS is listed on Nasdaq Stockholm (ticker: IRRAS).
For more information, please contact:
Kleanthis G. Xanthopoulos, Ph.D.
+46 73 951 95 02
The information was released for public disclosure, through the agency of the contact person above, on May 11, 2021 at 08:30 (CET).
This information was brought to you by Cision http://news.cision.com
Company Codes: Bloomberg:IRRAS@SS, ISIN:SE0008321202, RICS:IRRAS.ST, Stockholm:IRRAS
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INVO Bioscience Appoints Meryle Lynn Chamberlain to Lead Marketing for Global Brand Expansion
SARASOTA, Fla., May 10, 2021 /PRNewswire/ — INVO Bioscience, Inc. (NASDAQ: INVO), a medical device company focused on commercializing the world’s only in vivo Intravaginal Culture System (IVC), INVOcell®, an effective and affordable treatment for patients diagnosed with infertility, is pleased to announce the appointment of tenured women’s health & fertility solution marketing professional, Meryle Lynn Chamberlain, as Director of Marketing, a newly created position within the company.
Chamberlain brings over 15 years of marketing experience in the women’s health field including her most recent role as a Product Marketing Manager at Wildflower Health, a digital health company focused on women’s health and pregnancy and the Marketing Manager at The Emergency Nurses Association, an international healthcare organization, where she led integrated marketing strategies for all products, services and events. Ms. Chamberlain has a Bachelor of Arts degree in Political Science from Brigham Young University and the Integrated Marketing Certificate from DePaul University.
Chamberlain joined INVO Bioscience to spearhead and expand INVO Bioscience’s global marketing and brand management strategy for INVOcell. “INVOcell is a revolution for patients suffering from infertility,” said Chamberlain. “This is the only fertility treatment that allows fertilization to take place in the woman’s own body, eliminating the need for expensive lab equipment. I’m thrilled that I have the opportunity to help millions of women and couples realize their dreams of parenthood.”
Steve Shum, CEO of INVO Bioscience, commented, “We are excited to have Meryle Lynn, an experienced women’s healthcare marketing professional join the INVO Bioscience team. This is an exciting time in the history of the Company as we look to expand INVOcell’s adoption within the fertility industry through our planned INVO centers and global commercialization partners and provide affordable, expanded care to patients.
“With the recent addition of Rebecca Messina to our board of directors, who comes from an impressive global strategic marketing back-ground as the former Global CMO of Uber, Beam Suntory, and a 20+ year global career with Coca-Cola, along with the appointment of Meryle Lynn to lead our internal efforts, we have substantially strengthened our marketing capabilities to support the INVOcell-only centers and our growing number of distribution partners. I look forward to Meryle Lynn’s contributions to the team.”
About INVO Bioscience
We are a medical device company focused on creating simplified, lower-cost treatments for patients diagnosed with infertility. Our solution, the INVO® Procedure, is a revolutionary in vivo method of vaginal incubation that offers patients a more natural and intimate experience. Our lead product, the INVOcell®, is a patented medical device used in infertility treatment and is considered an Assisted Reproductive Technology (ART). The INVOcell® is the first Intravaginal Culture (IVC) system in the world used for the natural in vivo incubation of eggs and sperm during fertilization and early embryo development, as an alternative to traditional In Vitro Fertilization (IVF) and Intrauterine Insemination (IUI). Our mission is to increase access to care and expand fertility treatment across the globe with a goal to lower the cost of care and increase the availability of care. For more information, please visit http://invobioscience.com/.
Safe Harbor Statement
This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as “anticipate,” “if,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “could,” “should,” “will,” and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at www.sec.gov. We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE INVO Bioscience, Inc.
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