Medical Device

The Robotic Prostatectomy Marked the Start of the Hugo™ RAS System Global Patient Registry

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the first patient procedure with the Hugo™ robotic-assisted surgery (RAS) system. The robotic prostatectomy was performed June 19 by urological surgeon Ruben Olivares M.D., at Clínica Santa Maria in Santiago, Chile .

The first patient procedure marks the beginning of the Hugo RAS system patient registry, which will collect clinical data to support regulatory submissions around the world.

A modular, multi-quadrant platform designed for a broad range of surgical procedures, the Hugo RAS system combines wristed instruments, 3D visualization, and a powerful surgical video capture option in Touch Surgery™ Enterprise with dedicated support teams specializing in robotics program optimization, service, and training.

"I'm proud to have performed the very first clinical procedure with the Hugo RAS system," said Dr. Olivares. "From the open console and modular platform to the instrumentation I know and trust, this innovative system is truly a partner in the OR. I feel energized by the possibility the Hugo RAS system brings to patients and clinicians and am honored to help pave the way for future surgeons, being able to offer a minimal invasive alternative on a regular basis."

With the Hugo RAS system, Medtronic is building on its decades-long history of bringing the benefits of minimally invasive surgery (MIS) to more patients around the world. With MIS, patients experience fewer complications, shorter hospital stays, and faster return to normal activities. 1-3,†

RAS delivers the benefits of MIS, yet accounts for less than three percent of all surgeries performed today, 4 mostly due to historic cost and utilization barriers that put it out of reach for many hospitals. 5 A global leader in open and laparoscopic surgery, Medtronic designed the Hugo RAS system to help improve robotics economics and utilization — based on input from hundreds of clinicians and hospital executives.

"Today, with the start of our Hugo RAS system patient registry, we're taking an exciting step forward to bring the benefits of robotic-assisted surgery to more patients in more places," said Megan Rosengarten , president of the Surgical Robotics business, which is part of the Medical Surgical Portfolio at Medtronic. "That's possible thanks to our shared vision with Clínica Santa Maria, the first institution to join our Partners in Possibility Program, a group of pioneering hospitals that will be among the first in the world to use the Hugo RAS system in support of our patient registry."

Clínica Santa María has more than 10 years of experience in robotic surgery, and today the clinic incorporates this new technology to continue offering its patients world-class surgical options, with high standards of quality and safety.

"We are committed to providing the most advanced and innovative care to our patients. In this context, robotic surgery is a minimally invasive alternative that we have been performing with excellent results for more than a decade, with a total of more than 2,000 interventions of this type to date," said Martín Manterola, chief executive officer, Clínica Santa María. "The alliance with Medtronic and the incorporation of the Hugo™ RAS system to our center places us as the first health institution in the world to use this new technology and is a milestone that reinforces the dedication and experience of our medical team."

The Hugo RAS system is not cleared or approved in the U.S. or Europe . Regulatory requirements of individual countries and regions will determine availability and approval or clearance timelines. Touch Surgery Enterprise is not intended to direct surgery, or aid in diagnosis or treatment of a disease or condition.

About Medtronic
Medtronic plc ( www.medtronic.com ), headquartered in Dublin, Ireland , is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

†Compared to open surgery.

1 Fitch K, Engel T, Bochner A. Cost differences between open and minimally invasive surgery. Managed Care. 2015 Sep;24(9):40–8.
2 Tiwari MM, Reynoso JF, High R, Tsang AW, Oleynikov D. Safety, efficacy, and cost effectiveness of common laparoscopic procedures. Surg Endosc. 2011;25(4):1127-1135.
3 Roumm AR, Pizzi L, Goldfarb NI, Cohn H. Minimally invasive: minimally reimbursed? An examination of six laparoscopic surgical procedures. Surg Innovation. 2005;12(3):261–287.
4 Based on internal estimates and Medtronic report, FY20 market model: procedural volume data.
5 Based on internal report prepared by Consumer Dynamics: quantitative research with U.S. and European surgeons and hospital executives. March 21, 2020 .

Contacts:




Gary Jeanfaivre

Ryan Weispfenning

Public Relations

Investor Relations

+1-203-833-2104

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Medtronic plc (PRNewsfoto/Medtronic plc)

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New Study Shows Abbott's Blood Test for Concussion Could Predict Outcomes from Brain Injury and Inform Treatment Interventions

  • The study concluded that elevated levels of two proteins help predict how a person will recover from a traumatic brain injury (TBI), providing important information to determine appropriate care
  • Researchers used Abbott's i-STAT™ TBI Plasma test – the only FDA-cleared rapid test on a portable analyzer for concussion – and Abbott's core laboratory ARCHITECT instrument to measure two biomarkers in blood plasma associated with brain injury

A new study published in The Lancet Neurology demonstrates the ability of two blood-based biomarkers to predict how someone will recover from traumatic brain injury (TBI). Testing for these two biomarkers in the immediate aftermath of an injury can help health care providers determine the best way to treat and care for patients.

This research shows that when a clinician conducts a blood test for these brain proteins soon after a possible injury, they quickly get a more accurate picture of how severe the injury is, the expected course of recovery and the longer-term implications of the TBI. The markers were measured using Abbott's i-STAT™ TBI Plasma test , as well as on the company's ARCHITECT core laboratory instrument using research prototype assays, both of which helped predict recovery.

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Knight Therapeutics Reports Second Quarter 2022 Results

-- Achieves Record Quarterly Revenues and EBITDA 1 --

Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading pan-American (ex-US) specialty pharmaceutical company, today reported financial results for its second quarter ended June 30, 2022. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

Q2 2022 Highlights

Financials

  • Revenues were $75,820, an increase of $10,024 or 15% over the same period in prior year.
  • Gross margin of $38,295 or 51% compared to $28,871 or 44% in the same period in prior year.
  • Adjusted EBITDA 1 was $17,890, an increase of $8,494 or 90% over the same period in prior year.
  • Net loss on financial assets measured at fair value through profit or loss of $7,692.
  • Net income was $2,516, compared to net income of $29,004 in the same period in prior year.
  • Cash inflow from operations was $11,521, compared to a cash inflow from operations of $12,409 in the same period in prior year.

Corporate Developments

  • Purchased 1,460,684 common shares through Knight's normal course issuer bid ("NCIB") at an average price of $5.30 for an aggregate cash consideration of $7,739.
  • Shareholders re-elected Jonathan Ross Goodman, Samira Sakhia, James C. Gale, Robert N. Lande, Michael J. Tremblay, Nicolás Sujoy and Janice Murray on the Board of Directors.

Products

  • Entered into an exclusive license, distribution and supply agreement with Helsinn Healthcare SA ("Helsinn") for AKYNZEO® oral/IV (netupitant/palonosetron/fosnetupitant/palonosetron) in Canada, Brazil and select LATAM countries and ALOXI® oral/IV (palonosetron) in Canada.
  • Entered into exclusive license and supply agreements with Rigel Pharmaceuticals ("Rigel") to commercialize fostamatinib in LATAM.
  • Obtained marketing authorization transfer of Exelon® from Novartis to Knight in Colombia, Brazil, and Mexico, and transferred Exelon®'s commercial activities from Novartis to Knight's affiliate in Colombia.

Subsequent Events

  • Relaunched AKYNZEO® in Brazil in July 2022.
  • Transferred marketing authorization of Exelon® from Novartis to Knight's affiliate in Chile.
  • Executed a settlement agreement with former controlling shareholders of GBT and will receive US$4.6 million.
  • Launched a NCIB in July 2022 to purchase up to 7,988,986 common shares of the Company over the next 12 months.

"I am excited to announce that Knight achieved record quarterly revenues this quarter and see continuous growth in each of our key therapeutic categories primarily driven by the lifting of COVID-19 restrictions as well as the impact of the acquisition of Exelon®. Almost one year after closing that transaction, we have completed the Exelon® marketing authorization transfers to Knight in our key LATAM territories and have assumed Exelon® commercial activities in Colombia. We also continued to execute on the business development front and entered into exclusive license, distribution and supply agreements with Helsinn and Rigel in our key territories,", said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc.

__________
1 EBITDA and Adjusted EBITDA are a non-GAAP measures, refer to section "Non-GAAP measures" and "Reconciliation to adjusted EBITDA" for additional details


SELECT FINANCIAL RESULTS
[In thousands of Canadian dollars]

Change Change
Q2-22 Q2-21 $ 1 % 2 YTD-22 YTD-21 $ 1 % 2
Revenues 75,820 65,796 10,024 15% 139,627 111,865 27,762 25%
Gross margin 38,295 28,871 9,424 33% 70,772 49,451 21,321 43%
Gross margin % 51 % 44% 51% 44%
Operating expenses 4 35,959 28,855 7,104 25% 68,752 51,670 17,082 33%
Net income (loss) 2,516 29,004 (26,488 ) 91% (16,295 ) 32,562 (48,857 ) 150%
EBITDA 3 17,890 9,271 8,619 93% 31,202 14,431 16,771 116%
Adjusted EBITDA 3 17,890 9,396 8,494 90% 31,202 14,975 16,227 108%
  1. A positive variance represents a positive impact to net income (loss) and a negative variance represents a negative impact to net income (loss)
  2. Percentage change is presented in absolute values
  3. EBITDA and adjusted EBITDA are non-GAAP measures, refer to the definitions in section "Non-GAAP measures" for additional details
  4. Operating expenses include selling and marketing expenses, general and administrative expenses, research and development expenses, amortization and impairment of intangible assets


SELECT BALANCE SHEET ITEMS
[In thousands of Canadian dollars]

Change
06-30-22 12-31-21 $ % 1
Cash, cash equivalents and marketable securities 136,235 149,502 (13,267 ) 9 %
Trade and other receivables 131,570 103,875 27,695 27 %
Inventory 76,400 72,397 4,003 6 %
Financial assets 162,306 192,443 (30,137 ) 16 %
Accounts payable and accrued liabilities 82,635 65,590 17,045 26 %
Bank loans 32,483 35,927 (3,444 ) 10 %
  1. Percentage change is presented in absolute values

Revenues: For the quarter ended June 30, 2022 revenues increased by $10,024 or 15% compared to the same period in prior year. The growth in revenues excluding the impact of hyperinflation was $9,836 or 15% and is explained by the following:

  • Knight recognized revenues of $12,390 for Exelon®, an increase of $8,202 or 200% driven by the following factors:
    • The timing of the acquisition of Exelon® executed on May 26, 2021
    • Estimated increase in revenues between $4,000 to $4,500 driven by the purchasing pattern of certain customers as well as higher sales in Brazil in anticipation of the transfer of commercial activities from Novartis to Knight
  • An increase in revenues of $1,634 driven by the growth of recently launched products including the Q1-22 launches of Lenvima®, Rembre® and Halaven® in Colombia, an increase in patient treatments as our markets reduce COVID-19 restrictions and buying patterns offset by a decrease in revenues of certain of our oncology branded generics products due to market entrance of new competitors. In addition, revenues decreased by approximately $4,500 to $6,000 due to lower demand of certain of our infectious diseases products associated with COVID-19.

Gross margin: For the quarter ended June 30, 2022, gross margin increased from 44% to 51% explained by a change in product mix as well as the acquisition of Exelon®. The revenues of Exelon® is recorded as a net profit transfer from Novartis with the exception of revenues generated in Colombia upon the transfer of commercial activities to Knight in June 2022. The gross margin would have been 54% versus 51% (YTD-21: 44% to 46%) after excluding the adjustment of hyperinflation accounting in accordance with IAS 29.

Knight expects gross margin as a % of revenues to decline over the next quarters as the commercial activities of Exelon® are transferred to Knight on a country-by-country basis and the Company records revenues with related cost of sales instead of a net profit transfer.

Selling and marketing: For the quarter ended June 30, 2022, S&M expenses were $10,926, an increase of $1,742 or 19%, compared to the same period in prior year due to an increase in compensation expenses, certain variable costs such as logistics fees as well as an increase in selling and marketing activities related to key promoted products and Exelon®.

General and administrative: For the quarter ended June 30, 2022, G&A expenses were $10,566, an increased of $1,115 or 12%, compared to the same period in prior year due to an increase in compensation expense, certain consulting and professional fees partially offset by the lower costs of related to stock options

Research and development: For the quarter ended June 30, 2022, R&D expenses were $3,412, an increase of $827 or 32%, compared to the same period in prior year. The variance is not significant.

Amortization of intangible assets: For the quarter ended June 30, 2022, amortization of intangible assets was $11,055, an increase of $3,420 or 45%, compared to the same period in prior year driven by acquisition of Exelon®.

Interest income: Interest income is the sum of interest income on financial instruments measured at amortized cost and other interest income. For the quarter ended June 30, 2022, interest income was $2,427, an increase of 36% or $641, compared to the same period in prior year due to higher interest rates.

Interest expense: For the quarter ended June 30, 2022, interest expense was $1,717, an increase of $1,049 or 157%, compared to the same period in prior year due to higher interest rates partially offset by a lower average bank loan balance.

Adjusted EBITDA: For the quarter ended June 30, 2022, adjusted EBITDA increased by $8,494 or 90%. The growth in adjusted EBITDA is driven by an increase in gross margin of $9,424, offset by an increase in operating expenses.

Net loss or income: For the quarter ended June 30, 2022, net income was $2,516 compared to net income of $29,004 for the same period in prior year. The variance mainly resulted from the above-mentioned items and (1) a net loss on the revaluation of financial assets measured at fair value through profit or loss of $7,692 versus a net gain of $28,472 in the same period in prior year, mainly due to unrealized revaluations of the strategic fund investments, offset by (2) a foreign exchange gain of $4,507 mainly due to the unrealized gains on intercompany balances driven by the appreciation of the USD compared to a foreign exchange loss of $3,194 in the same period in prior year mainly due to depreciation of the USD.

Cash, cash equivalents and marketable securities : As at June 30, 2022, Knight had $136,235 in cash, cash equivalents and marketable securities, a decrease of $13,267 or 9% as compared to December 31, 2021. The variance is primarily due to outflows related to due to upfront payments and certain milestones mainly related to in-licensing of AKYNZEO® and ALOXI® from Helsinn as well as fostamatinib from Rigel, shares repurchased through NCIB, partially offset by cash inflows from operating activities.

Financial assets: As at June 30, 2022, financial assets were at $162,306, a decrease of $30,137 or 16%, as compared to the prior year, mainly due to negative mark-to-market adjustments of $23,520 driven by the decline in the share prices of the publicly-traded equities of our strategic fund investments due to general market conditions and distributions of $4,336. Given the nature of the fund investments there could be significant fluctuations in the fair value of the underlying assets.

Bank Loans: As at June 30, 2022, bank loans were at $32,483, a decrease of $3,444 or 10% as compared to the prior period, due to loan repayments of $5,391, partially offset by the appreciation of BRL and accrued interest.

Product Updates

The marketing authorizations of Exelon® for Colombia, Mexico, Chile and Brazil were transferred to Knight. The Company expects that remaining marketing authorizations will be transferred in the second half of 2022. Furthermore, Knight has assumed the commercial activities of Exelon® in Colombia and expects to assume commercial activities in Brazil, Mexico and Chile in Q3-22.

Knight entered into an exclusive license, distribution and supply agreement with Helsinn for AKYNZEO® oral/IV (netupitant/palonosetron / fosnetupitant/palonosetron) in Canada, Brazil and select LATAM countries and ALOXI® oral/IV (palonosetron) in Canada. AKYNZEO ® oral is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone in adults. AKYNZEO ® oral is also approved and marketed in Argentina and Brazil for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. ALOXI® solution for injection is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy and highly emetogenic cancer chemotherapy, including high dose cisplatin in adults. In Canada, the product is also indicated in pediatric patients aged 2 to 17 years for the prevention of acute nausea and vomiting associated with moderately and highly emetogenic cancer chemotherapy. ALOXI® oral is approved in Canada for use in adults for the prevention of acute nausea and vomiting associated with moderately emetogenic cancer chemotherapy. According to IQVIA, sales of AKYNZEO® in Canada and Brazil were approximately $7 million in 2021. Knight assumed commercial activities of AKYNZEO® in Brazil and Argentina in July 2022 and will begin commercial activities following a transition period from Helsinn's current licensees in Canada.

Knight entered into exclusive license and supply agreements with Rigel Pharmaceuticals for the exclusive rights to commercialize fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in Latin America. Fostamatinib is commercially available in the United States under the brand name TAVALISSE® and in Europe under the brand name TAVLESSE® for the treatment of chronic immune thrombocytopenia. On June 8, 2022, Rigel announced topline efficacy and safety data from the Phase 3 clinical trial of fostamatinib in patients with warm autoimmune hemolytic anemia (wAIHA). The trial did not demonstrate statistical significance in the primary efficacy endpoint of durable hemoglobin response in the overall study population. The safety profile was consistent with prior clinical experience, and no new safety issues were identified. Rigel is conducting an in-depth analysis of this data to better understand differences in patient characteristics and outcomes and expects to discuss these findings with the FDA to determine the path forward in wAIHA. Fostamatinib is also in Phase 3 clinical trials for the treatment of hospitalized patients with COVID-19 1,2 .

_______________

1 Clinicaltrials.gov: NCT04629703
2 Clinicaltrials.gov: NCT04924660


Corporate Updates

NCIB

On July 12, 2022, the Company announced that the Toronto Stock Exchange approved its notice of intention to launch a NCIB ("2022 NCIB"). Under the terms of the 2022 NCIB, Knight may purchase for cancellation up to 7,988,986 common shares of the Company which represented 10% of its public float as at June 30, 2022. The 2022 NCIB commenced on July 14, 2022 and will end on the earlier of July 13, 2023 or when the Company completes its maximum purchases under the NCIB. Furthermore, Knight entered into an agreement with a broker to facilitate purchases of its common shares under the NCIB. Under Knight's automatic share purchase plan, the broker may purchase common shares which would ordinarily not be permitted due to regulatory restrictions or self-imposed blackout periods.

For the three-month period ended June 30, 2022, the Company purchased 1,460,684 common shares at an average price of $5.30 for an aggregate cash consideration of $7,739. The Company did not acquire any common shares subsequent to the quarter ended June 30, 2022.

Settlement Agreement

Knight executed a settlement agreement and general release ("Settlement Agreement") with the former shareholders of GBT. The Company made certain claims ("Claims") with respect to its indemnification rights under the purchase agreement for the acquisition of GBT. Under the Settlement Agreement, Knight will receive $5.9 million (US$4.6 million) as settlement for the Claims, which will be recorded in the Statement of Income.

Conference Call Notice

Knight will host a conference call and audio webcast to discuss its second quarter ended June 30, 2022, today at 8:30 am ET. Knight cordially invites all interested parties to participate in this call.

Date: Thursday, August 11, 2022
Time: 8:30 a.m. ET
Telephone : Toll Free: 1-855-669-9657 or International 1-412-317-0790
Webcast: www.gud-knight.com or Webcast
This is a listen-only audio webcast. Media Player is required to listen to the broadcast.

Replay: An archived replay will be available for 30 days at www.gud-knight.com

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Bausch Health to Appeal XIFAXAN® Patent Decision to U.S. Court of Appeals for the Federal Circuit

Bausch Health Companies Inc. (NYSETSX: BHC), and its gastroenterology business Salix Pharmaceuticals, today announced that, consistent with the company's July 28, 2022 press release, the U.S. District Court of Delaware has issued a decision in the matter of Salix Pharmaceuticals, Ltd. et al v. Norwich Pharmaceuticals, Inc. finding certain XIFAXAN® (rifaximin) 550 mg HE patents valid and infringed and certain XIFAXAN composition and IBS-D patents invalid.  As previously stated, the Company will appeal this decision to the U.S. Court of Appeals for the Federal Circuit and it expects an appeal decision to issue within 12 to 18 months.

To date, Norwich has not received tentative or final approval of its ANDA from the FDA.  Unless and until FDA approves a revised Norwich ANDA that omits the XIFAXAN HE indication, and any injunction issued by the Court is modified, Norwich is not permitted to launch a generic equivalent of XIFAXIN.

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Medtronic to announce financial results for its first quarter of fiscal year 2023

Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that it will report financial results for its first quarter of fiscal year 2023 on Tuesday, August 23, 2022 . A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at https:news.medtronic.com . The news release will include summary financial information for the company's first quarter of fiscal year 2023, which ended on Friday, July 29, 2022 .

Medtronic will host a video webcast at 7:00 a.m. CDT on Tuesday, August 23, 2022 , to discuss results for its first quarter of fiscal year 2023. The webcast can be accessed at https://investorrelations.medtronic.com .

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Salix Supports CMS Announcement of First ICD-10 Code for Hepatic Encephalopathy

CMS Issues New Specific ICD-10 Code K76.82 for HE

Bausch Health Companies Inc. (NYSETSX: BHC) ("Bausch Health") and its gastroenterology business, Salix Pharmaceuticals, ("Salix"), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal (GI) and liver diseases and disorders, today announced its support of the publication of a new specific ICD-10 code from the Centers for Medicare & Medicaid Services (CMS) for hepatic encephalopathy (HE) based on the growing incidence of chronic liver disease in the United States.

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Johnson & Johnson to Participate in the Morgan Stanley 20th Annual Global Healthcare Conference

Johnson & Johnson (NYSE: JNJ) will participate in the Morgan Stanley 20 th Annual Global Healthcare Conference on Wednesday, September 14 th , at the Sheraton New York Hotel in New York. Joaquin Duato, Chief Executive Officer, and Joseph J. Wolk, Executive Vice President and Chief Financial Officer will represent the Company in a session scheduled at 11:10 a.m. (Eastern Time).

This live audio webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com .

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