On August 3, 2021 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported that it will release second quarter 2021 financial results and provide a Company update after the market closes on Tuesday, August 10, 2021 (Press release, Cumberland Pharmaceuticals, AUG 3, 2021, View Source [SID1234585660]). A conference call and live internet webcast will be held on Tuesday, August 10, 2021, at 4:30 p.m. Eastern Time to discuss the results.

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To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 3985462. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source

Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the delivery of branded prescription products to improve patient care. The Company develops, acquires and commercializes brands for the hospital acute care, gastroenterology and rheumatoid arthritis markets.

The Company’s portfolio of FDA-approved brands includes:

Acetadote (acetylcysteine) Injection, for the treatment of acetaminophen poisoning;
Caldolor (ibuprofen) Injection, for the treatment of pain and fever;
Kristalose (lactulose) for Oral Solution, a prescription laxative, for the treatment of constipation;
Omeclamox-Pak, (omeprazole, clarithromycin, amoxicillin) for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease;
RediTrex (methotrexate) Injection, for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as well as disabling psoriasis;
Vaprisol (conivaptan) Injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and
Vibativ (telavancin) Injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.
The Company also has Phase II clinical programs underway evaluating its product candidates in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy ("DMD"), Systemic Sclerosis ("SSc"), and Aspirin-Exacerbated Respiratory Disease ("AERD").

For more information on Cumberland’s approved products, including full prescribing information, please visit links to the individual product websites, which can be found on the Company’s website www.cumberlandpharma.com.

On August 3, 2021 Unum Group (NYSE: UNM) reported net income of $182.9 million ($0.89 per diluted common share) for the second quarter of 2021, compared to net income of $265.5 million ($1.30 per diluted common share) for the second quarter of 2020 (Press release, Unum Therapeutics, AUG 3, 2021, View Source [SID1234585659]).

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Unum Group Reports Second Quarter 2021 Results
Included in net income for the second quarter of 2021 are the after-tax cost related to the early retirement of debt of $53.2 million ($0.26 per diluted common share), an after-tax impairment loss on the right-of-use (ROU) asset related to one of our operating leases for office space that we are no longer using to support our general operations of $11.0 million ($0.05 per diluted common share), the net tax expense related to a U.K. tax rate increase of $24.2 million ($0.12 per diluted common share), the after-tax amortization of the cost of reinsurance of $15.5 million ($0.08 per diluted common share), and a net after-tax realized investment gain on the Company’s investment portfolio of $0.6 million ($0.01 per diluted common share). Included in net income for the second quarter of 2020 are an after-tax impairment loss on the ROU asset of $10.0 million ($0.05 per diluted common share), as well as well as a net after-tax realized investment gain on the Company’s investment portfolio of $25.4 million ($0.12 per diluted common share). Excluding the items above, after-tax adjusted operating income was $286.2 million ($1.39 per diluted common share) in the second quarter of 2021, compared to $250.1 million ($1.23 per diluted common share) in the second quarter of 2020.

"We are very pleased with our strong second quarter results, highlighted by positive investment returns and aided by improved COVID dynamics relative to the first quarter. Our core business segments exhibited solid underlying fundamental trends, with improving sales and overall stable benefits experience," said Richard P. McKenney, president and chief executive officer. "These favorable results drive an improvement in our outlook for the full year, which we expect to continue to be influenced by the pandemic."

RESULTS BY SEGMENT

We measure and analyze our segment performance on the basis of "adjusted operating income" or "adjusted operating loss", which differ from income before income tax as presented in our consolidated statements of income due to the exclusion of net realized investment gains and losses, amortization of cost of reinsurance, and certain other items. These performance measures are in accordance with GAAP guidance for segment reporting, but they should not be viewed as a substitute for income before income tax or net income.

Unum US Segment

Unum US reported adjusted operating income of $179.3 million in the second quarter of 2021, a decrease of 22.7 percent from $231.9 million in the second quarter of 2020. Premium income for the segment was $1,522.1 million in the second quarter of 2021, which was generally consistent with the $1,522.7 million in the second quarter of 2020. Net investment income for the segment increased 3.8 percent to $183.6 million in the second quarter of 2021, compared to $176.9 million in the second quarter of 2020.

Within the Unum US operating segment, the group disability line of business reported a 21.2 percent decrease in adjusted operating income to $59.9 million in the second quarter of 2021, compared to $76.0 million in the second quarter of 2020. Premium income for the group disability line of business increased 1.1 percent to $672.2 million in the second quarter of 2021, compared to $664.6 million in the second quarter of 2020, due to higher sales in the group short-term disability product line. Net investment income decreased 2.6 percent to $94.0 million in the second quarter of 2021, compared to $96.5 million in the second quarter of 2020, due to a decline in the yield on invested assets and a lower level of invested assets, partially offset by higher miscellaneous investment income. The benefit ratio for the second quarter of 2021 was 74.7 percent, compared to 72.8 percent in the second quarter of 2020, due to higher claims incidence in the group short-term disability product line. Group long-term disability sales were $42.0 million in the second quarter of 2021, a decrease of 23.9 percent from $55.2 million in the second quarter of 2020. Group short-term disability sales were $31.2 million in the second quarter of 2021, an increase of 5.4 percent from $29.6 million in the second quarter of 2020. Persistency in the group long-term disability product line was 90.1 percent for the first half of 2021, compared to 89.4 percent for the first half of 2020. Persistency in the group short-term disability product line was 87.2 percent for the first half of 2021, compared to 86.9 percent for the first half of 2020.

The group life and accidental death and dismemberment line of business reported adjusted operating income of $5.2 million in the second quarter of 2021, a decrease of 73.2 percent from $19.4 million in the second quarter of 2020. Premium income for this line of business was $456.6 million in the second quarter of 2021, which was generally consistent with the $456.3 million in the second quarter of 2020. Net investment income increased 15.5 percent to $26.9 million in the second quarter of 2021, compared to $23.3 million in the second quarter of 2020, due to higher miscellaneous investment income, partially offset by a decline in the yield on invested assets. The benefit ratio in the second quarter of 2021 was 85.2 percent, compared to 81.8 percent in the second quarter of 2020, due primarily to higher average claim size in the group life product line. Sales of group life and accidental death and dismemberment products increased 12.7 percent in the second quarter of 2021 to $63.8 million, compared to $56.6 million in the second quarter of 2020. Persistency in the group life product line was 90.1 percent for the first half of 2021, compared to 88.6 percent for the first half of 2020. Persistency in the accidental death and dismemberment product line was 89.6 percent for the first half of 2021, compared to 87.8 percent for the first half of 2020.

The supplemental and voluntary line of business reported a decrease of 16.3 percent in adjusted operating income to $114.2 million in the second quarter of 2021, compared to $136.5 million in the second quarter of 2020. Premium income for the supplemental and voluntary line of business decreased 2.1 percent to $393.3 million in the second quarter of 2021, compared to $401.8 million in the second quarter of 2020, due to a decline in the voluntary benefits product line as a result of lower sales, partially offset by growth in the dental and vision product line. Net investment income increased 9.8 percent to $62.7 million in the second quarter of 2021, compared to $57.1 million in the second quarter of 2020, due to higher miscellaneous investment income, partially offset by a decline in the yield on invested assets. The benefit ratio for the individual disability product line was 48.4 percent for the second quarter of 2021, compared to 52.8 percent for the second quarter of 2020, due primarily to lower claims incidence. The benefit ratio for the voluntary benefits product line was 44.2 percent in the second quarter of 2021, compared to 43.1 percent for the second quarter of 2020, due to higher claims incidence in the group critical illness product line. The benefit ratio for the dental and vision product line was 77.1 percent for the second quarter of 2021, compared to 36.0 percent for the second quarter of 2020, due to higher utilization compared to lower utilization experienced in the same period of 2020 resulting from the impacts of COVID-19. Relative to the second quarter of 2020, sales in the individual disability product line increased 4.9 percent in the second quarter of 2021 to $14.9 million. Sales in the voluntary benefits product line declined 7.0 percent in the second quarter of 2021 to $43.7 million. Sales in the dental and vision product line totaled $13.0 million for the second quarter of 2021, an increase of 2.4 percent compared to the second quarter of 2020. Persistency in the individual disability product line was 89.0 percent for the first half of 2021, compared to 90.1 percent for the first half of 2020. Persistency in the voluntary benefits product line was 74.5 percent for the first half of 2021, compared to 73.0 percent for the first half of 2020. Persistency in the dental and vision product line was 86.6 percent for the first half of 2021, compared to 81.7 percent for the first half of 2020.

Unum International

The Unum International segment reported adjusted operating income of $24.8 million in the second quarter of 2021, an increase of 64.2 percent from $15.1 million in the second quarter of 2020. Premium income increased 16.8 percent to $183.5 million in the second quarter of 2021, compared to $157.1 million in the second quarter of 2020. Net investment income increased 35.7 percent to $35.7 million in the second quarter of 2021, compared to $26.3 million in the second quarter of 2020. Sales increased 10.0 percent to $33.1 million in the second quarter of 2021, compared to $30.1 million in the second quarter of 2020.

The Unum UK line of business reported adjusted operating income, in local currency, of £16.8 million in the second quarter of 2021, an increase of 66.3 percent from £10.1 million in the second quarter of 2020. Premium income was £115.1 million in the second quarter of 2021, an increase of 3.0 percent from £111.7 million in the second quarter of 2020, due to growth in the in-force block resulting from the impact of rate increases in the group long-term disability product line and higher overall persistency. Net investment income was £24.3 million in the second quarter of 2021, an increase of 22.1 percent from £19.9 million in the second quarter of 2020, due to higher investment income from inflation index-linked bonds, partially offset by a lower yield on fixed-rate bonds. The benefit ratio in the second quarter of 2021 was 82.5 percent, which was consistent with the second quarter of 2020, with improved experience in the group long-term disability product line and lower claims incidence in the group life product line, offset by higher inflation-linked experience in benefits. Sales decreased 3.2 percent to £21.2 million in the second quarter of 2021, compared to £21.9 million in the second quarter of 2020. Persistency in the group long-term disability product line was 89.4 percent for the first half of 2021, compared to 87.7 percent for the first half of 2020. Persistency in the group life product line was 84.3 percent for the first half of 2021, compared to 83.0 percent for the first half of 2020. Persistency in the supplemental product line was 89.2 percent for the first half of 2021, compared to 90.5 percent for the first half of 2020.

Colonial Life Segment

Colonial Life reported a 5.4 percent increase in adjusted operating income to $95.8 million in the second quarter of 2021, compared to $90.9 million in the second quarter of 2020. Premium income decreased 4.3 percent to $419.7 million in the second quarter of 2021, compared to $438.6 million in the second quarter of 2020, due to lower prior period sales. Net investment income increased 13.0 percent to $41.6 million in the second quarter of 2021, compared to the $36.8 million in the second quarter of 2020, due to higher miscellaneous investment income and a higher level of invested assets, partially offset by a decline in the yield on invested assets. The benefit ratio was 51.7 percent in the second quarter of 2021, compared to 50.7 percent in the second quarter of 2020, with unfavorable experience in the accident, sickness, and disability product line, partially offset by improved experience in the life product line.

Sales increased 53.7 percent to $111.1 million in the second quarter of 2021, compared to $72.3 million in the second quarter of 2020. Persistency in Colonial Life was 78.3 percent for the first half of 2021, compared to 77.5 percent for the first half of 2020.

Closed Block Segment

The Closed Block segment reported adjusted operating income of $111.2 million in the second quarter of 2021, an increase from the $36.7 million in the second quarter of 2020. Premium income for this segment declined 0.5 percent in the second quarter of 2021, compared to the second quarter of 2020, due to policy terminations mostly offset by rate increases on certain in-force business in the long-term care line of business. Net investment income decreased 9.7 percent to $294.7 million in the second quarter of 2021, compared to $326.3 million in the second quarter of 2020, due to a decrease in the level of invested assets supporting the individual disability line of business resulting from the reinsurance transaction that occurred in the first quarter of 2021 and fourth quarter of 2020, as well as a decline in the yield on invested assets. These decreases were partially offset by higher miscellaneous investment income, primarily related to increases in the net asset values on our private equity partnerships.

The interest adjusted loss ratio for the long-term care line of business was 74.6 percent in the second quarter of 2021, compared to an interest adjusted loss ratio of 67.0 percent in the second quarter of 2020, driven primarily by lower claimant mortality. The interest adjusted loss ratio for long-term care for the rolling twelve months ended June 30, 2021, excluding the update of assumptions during the fourth quarter of 2020, was 70.0 percent which is below our long-term expected range. The interest adjusted loss ratio for the individual disability line of business was 69.6 percent in the second quarter of 2021, compared to 89.5 percent in the second quarter of 2020, driven primarily by lower submitted claims.

Corporate Segment

The Corporate segment reported an adjusted operating loss of $48.5 million in the second quarter of 2021, which excludes the before-tax cost related to the early retirement of debt of $67.3 million and the before-tax impairment loss on the ROU asset of $13.9 million, compared to an adjusted operating loss of $58.1 million in the second quarter of 2020, which excludes the before-tax impairment loss on the ROU asset of $12.7 million.

OTHER INFORMATION

Shares Outstanding

The Company’s weighted average number of shares outstanding, assuming dilution, was 205.3 million for the second quarter of 2021, compared to 203.7 million for the second quarter of 2020. Shares outstanding totaled 204.3 million at June 30, 2021. The Company did not repurchase shares during the first half of 2021.

Capital Management

At June 30, 2021, the weighted average risk-based capital ratio for the Company’s traditional U.S. insurance companies was approximately 375 percent, and cash and marketable securities in the holding companies equaled $1,717.0 million.

Book Value

Book value per common share as of June 30, 2021 was $53.57, compared to $51.90 at June 30, 2020.

Outlook

The Company expects a decline of approximately 1 percent to 3 percent in after-tax adjusted operating income per share for full-year 2021 relative to full-year 2020, compared to its previous expectation of a 5 percent to 6 percent decline. The improved outlook reflects strong second quarter performance, and the Company’s revised expectations

On August 3, 2021 Nordic Nanovector ASA (OSE: NANOV) reported an update on the timeline for PARADIGME, its ongoing pivotal Phase 2b trial of Betalutin (177Lu lilotomab satetraxetan) in 3rd-line relapsed rituximab/anti-CD20 refractory follicular lymphoma (3L R/R FL) (Press release, Nordic Nanovector, AUG 3, 2021, View Source [SID1234585658]). The Company, having reviewed the recent rate of patient recruitment in discussion with its clinical advisors and in light of the continuing impact from the COVID pandemic, now anticipates the preliminary three-month data readout from PARADIGME during the first half of 2022.

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The Company will host a live webcast and Q&A on Thursday, 5 August 2021, at 08.30 CEST. A link to the webcast will be available in the afternoon on Wednesday, 4 August on www.nordicnanovector.com.

The Company reports that 92 patients have been enrolled into PARADIGME as of 3 August, compared with 83 patients enrolled as of 25 May 2021 and 73 as of 17 February 2021.

While the changes to the PARADIGME protocol and initiatives implemented to improve execution of the trial have positively impacted recruitment, the ongoing COVID pandemic situation, exacerbated by the spread of the more infectious SARS-CoV-2 delta variant, continues to affect the Company’s ability to screen, enrol and treat new patients. This is because the physical condition of the patient population targeted for this study means they are at the greatest risk from COVID-19 infection. As a result, the rate of patient recruitment has been slower than anticipated.

Nordic Nanovector continues to prioritise and commit all necessary resources to the completion of PARADIGME. As part of this prioritisation, Nordic Nanovector has decided to close clinical sites at which enrolment has been particularly challenging and refocus resources on other initiatives; the trial remains open for enrolment at 85 sites. The Company’s current cash position will support its operations into H2 2022.

In addition, the Company confirms it will invest no further funds in its Archer-1 Phase 1b trial investigating Betalutin in combination with rituximab in 2nd-line FL. The findings from this study, announced on 25 May 2021, will be important to inform the future development strategy for Betalutin in 2L FL.

The Company is planning to host an R&D Day for analysts, investors and press in Q4 2021. At the event, senior management and selected external speakers will discuss the positioning of Betalutin as a potential new treatment for R/R FL and outline the strategy for its future development and commercialisation in this indication pending positive results. In addition, the Company will discuss its multiple opportunities to expand the market for Betalutin and present other projects in its portfolio.

Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, commented: "The positive changes to the trial protocol and the initiatives we have implemented have increased the rate of recruitment into PARADIGME. However, they have not led to the expected acceleration in enrolment rate due to the spread of the emerging delta variant, which has meant that COVID restrictions have continued to impede the progress of PARADIGME, in common with many other clinical trials. Given this situation, we believe it is prudent to reset the anticipated timeline for completing the study, as we continue to focus on delivering preliminary top line data as soon as possible."

On August 3, 2021 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), reported the pricing of an underwritten public offering of 8,000,000 shares of its common stock at a price to the public of $18.00 per share (Press release, Avidity Biosciences, AUG 3, 2021, View Source [SID1234585657]). All of the shares to be sold in the offering are to be sold by Avidity. The gross proceeds to Avidity from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be $144.0 million. The offering is expected to close on or about August 6, 2021, subject to the satisfaction of customary closing conditions. In addition, Avidity has granted the underwriters a 30-day option to purchase up to an additional 1,200,000 shares of common stock.

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Avidity intends to use the net proceeds from this offering, together with its existing cash, cash equivalents and marketable securities: to complete its Phase 1/2 MARINA trial for AOC 1001; to advance AOC 1044 and its AOC FSHD program into clinical development; to further advance its AOC platform in and beyond its muscle franchise; and towards working capital and other general corporate purposes.

Cowen, SVB Leerink, Evercore ISI and Wells Fargo Securities are acting as joint bookrunning managers for the offering.

The securities described above are being offered by Avidity pursuant to a shelf registration statement that became automatically effective upon filing with the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering were filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC. The offering may be made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; from SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; from Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at [email protected]; or from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, NY 10001, or by telephone at (800) 326-5897, or by email at [email protected]. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the website of the SEC at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On August 3, 2021 NaviFUS’ focused ultrasound (FUS) therapy system (NaviFUS) reported that it was recently approved for use in a new clinical trial by the Taiwan Food and Drug Administration (TFDA). It will be initiated shortly at Linkou Chang Gung Memorial Hospital (Press release, NaviFUS, AUG 3, 2021, View Source [SID1234585656]). The trial will investigate the "synergy" that FUS-mediated opening of the blood-brain barrier (BBB) has on improving the therapeutic effect of radiotherapy treatment in patients with end-stage primary brain tumors. Despite suffering from repeating surgeries, radiotherapy, and chemotherapy, most of these patients will eventually face tumor recurrence. Currently, while there may not be any effective treatments guaranteed to prolong survival, NaviFUS hopes that this upcoming clinical trial can result in a new, low-risk, and "Patient Friendly" option for patients who have already exhausted first and second-line treatments or failed radiotherapy treatment previously. If this combined treatment can safely enhance the effect of radiotherapy, NaviFUS’ believes this treatment can also be extended to metastatic brain tumors from lung cancer, breast cancer, etc. The market potential for this treatment is expected to be more than $2 billion US dollars.

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The principle behind the "synergy" of this combined treatment is based on findings that the blood flow and oxygen concentration in the tumor area are often insufficient due to rapid proliferation of tumor cells. As a result of these hypoxic conditions, free radicals are not easily generated during radiation treatment, resulting in low radiotherapy efficacy; the opening of the blood-brain barrier is expected to change the tumor microenvironment by improving the blood flow and oxygen content of tumor tissues, which promotes the formation of free radicals and produces a radio-sensitization effect, so that the same dose of radiotherapy may bring better results without adding negative side effects.

NaviFUS has successively published research on how the opening of the BBB can enhance the therapeutic effect of radiotherapy last year at Focused Ultrasound Foundation’s International Symposium on Focused Ultrasound and this year at International Symposium for Therapeutic Ultrasound (ISTU 2021). In preclinical studies, preliminary results confirmed that the oxygen content of brain tissue is significantly increased after opening the BBB, resulting in an enhanced radiotherapy and tumor-inhibiting effect. Under these conditions, low radiotherapy doses may yield high-dose therapeutic effects and significantly reduced serious side effects attributed to high-dose radiotherapy.

At the same time, NaviFUS is conducting a FUS-mediated BBB opening combined with bevacizumab (Avastin) clinical trial at Linkou Chang Gung Memorial Hospital. After repeatedly opening the BBB and long-term treatment with Avastin, preliminary results have shown positive signs of superior tumor progression control at the tumor treatment sites in patients; NaviFUS plans to run a similar trial simultaneously at Stanford University, which they expect to be approved by the US FDA’s IDE review before the end of the year.

Dr. Arthur Lung, Chief Executive Officer of NaviFUS, expresses great optimism about the therapeutic potential of the NaviFUS System. "If these two non-invasive FUS treatments for brain tumors can be successfully developed, they can offer non-invasive treatment options with improved efficacy and minimal side effects." As the NaviFUS System continues its development of next-generation treatments on its platform, it has garnered much interest worldwide and has partnered with organizations conducting clinical or academic research in FUS through its Research-Only FUS device. For further inquiries on this model, please contact NaviFUS directly.