On January 7, 2021 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported financial results for the second quarter of fiscal year 2021, which ended November 30, 2020 (Press release, AngioDynamics, JAN 7, 2021, View Source [SID1234573652]).

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"I am very pleased with our performance in the second quarter, as sales execution and continued expense management drove strong revenue and positive earnings," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "AngioVac and Auryon performed well during the quarter, as we continue to focus on growing our key technology platforms while managing expenses throughout the business. In the second half of the year, we expect ongoing COVID-related headwinds as well as typical third-quarter seasonality, which is contemplated in our full-year guidance. We are excited about the planned launch of our multi-purpose mechanical aspiration thrombectomy device in calendar 2021, as this new member of the AngioVac platform family will position us to serve the much larger addressable market of moderately complex thrombectomy cases, while AngioVac and Uni-Fuse continue to address the complex and simple ends of the spectrum, respectively."

Second Quarter 2021 Financial Results

Net sales for the second quarter of fiscal 2021 were $72.8 million, an increase of 4.0% compared to the prior-year quarter. Net sales in the second quarter continued to be impacted by the disruption to procedure volumes resulting from the COVID-19 global pandemic. Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Vascular Interventions and Therapies ("VIT") net sales were $33.9 million, an increase of 8.8%, compared to $31.2 million a year ago. Growth was driven by increased AngioVac sales over the previous year, partially offset by a decline in sales of Venous products resulting from lower elective procedure volumes. Auryon sales during the quarter were $2.1 million.
Oncology net sales were $14.9 million, a decrease of 7.0% from $16.0 million a year ago. The year-over-year decline was primarily attributable to lower capital sales, which were somewhat offset by strong growth in sales of NanoKnife disposables, particularly in the United States.
Vascular Access net sales were $23.9 million, an increase of 5.0% from $22.8 million a year ago.
U.S. net sales in the second quarter of fiscal 2021 were $60.7 million, an increase of 9.2% from $55.6 million a year ago. International net sales were $12.1 million in the second quarter of fiscal 2021, a decrease of 16.3% from $14.4 million a year ago.

Gross margin for the second quarter of fiscal 2021 was 55.2%, a decline of 410 basis points compared to the second quarter of fiscal 2020. The gross margin decline was primarily attributable to the Company’s previously discussed COVID-related operating plan. This plan included under-absorption of the Company’s manufacturing facilities related to additional COVID-related operating protocols designed to ensure supply-chain security and employee safety. Additionally, during the second quarter, inventory was reduced by $3.2 million when compared to inventory levels on August 31, 2020. Since year end, inventory levels have been reduced by $10.3 million.

The Company recorded a net loss of $4.3 million, or loss per share of $0.11, in the second quarter of fiscal 2021. This compares to net loss of approximately $2.7 million, or loss per share of $0.07, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the second quarter of fiscal 2021 was $0.6 million or adjusted earnings of $0.01 per share, compared to adjusted net income of $2.2 million, or adjusted earnings per share of $0.06, in the second quarter of fiscal 2020.

Adjusted EBITDA in the second quarter of fiscal 2021, excluding the items shown in the reconciliation table below, was $5.2 million, compared to $6.4 million in the second quarter of fiscal 2020.

In the second quarter of fiscal 2021, the Company generated $11.5 million in operating cash and had capital expenditures of $1.4 million. As of November 30, 2020, the Company had $58.0 million in cash and cash equivalents compared to $47.9 million in cash and cash equivalents on August 31, 2020. As of November 30, 2020, the Company had $40.0 million in debt outstanding, consistent with its debt balance on August 31, 2020. Subsequent to quarter end, the Company repaid $10 million of its outstanding debt. Management remains focused on cash preservation amid the current environment.

Six Months Financial Results

For the six months ended November 30, 2020:

Net sales were $143.0 million, an increase of 5.1%, compared to $136.0 million for the same period a year ago.
The Company’s net loss was $9.0 million, or a loss of $0.22 per share, compared to a net loss of $4.0 million, or a loss of $0.11 per share, a year ago.
Gross margin decreased 550 basis points to 53.1% from 58.6% a year ago due to the Company’s previously discussed COVID-related operating plan.
Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income was $1.2 million, or $0.03 per share, compared to adjusted net income of $5.3 million, or $0.14 per share, a year ago.
Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $9.6 million, compared to $13.7 million for the same period a year ago.
Fiscal Year 2021 Financial Guidance

The Company continues to expect fiscal year 2021 net sales in the range of $278 to $284 million and fiscal year 2021 adjusted earnings per share in the range of $0.00 to $0.05.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fiscal 2021 second quarter results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13714154.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, January 7, 2021, until 11:59 p.m. ET on Thursday, January 14, 2021. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13714154.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDA, adjusted net income, adjusted earnings per share, and free cash flow. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.

On January 7, 2021 AVEO Oncology (Nasdaq: AVEO) reported its recent progress and outlined its 2021 outlook (Press release, AVEO, JAN 7, 2021, View Source [SID1234573650]).

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"We remain keenly focused on building out our commercial team ahead of the potential U.S. launch of tivozanib as a treatment for relapsed or refractory renal cell carcinoma (RCC), including the addition of Dr. Corinne Epperly to our Board of Directors," said Michael Bailey, president and chief executive officer of AVEO. "If approved, we believe tivozanib has the potential to serve as a new treatment for the rapidly growing population of patients with relapsed or refractory RCC. In support of the further clinical and commercial development of tivozanib, we have identified opportunities to potentially extend its patent exclusivity period."

Mr. Bailey added: "In addition to our launch preparation, we continue to make great progress advancing our clinical pipeline, with each asset expected to reach an important milestone this year. These include progress in our immunotherapy combination programs for tivozanib, a decision on whether to initiate a pivotal study of ficlatuzumab in head and neck squamous cell carcinoma (HNSCC), and the execution of our Phase 1 study of AV-380. We believe 2021 will be a transformational year for AVEO, and we look forward to delivering on a number of milestones designed to enhance our long-term value."

Key Recent Program Updates and Anticipated 2021 Milestones

Tivozanib U.S. Regulatory and Commercial Updates

Commercial Readiness Nearing Completion in Support of Potential Tivozanib U.S. Launch. Commercial preparations are well underway to support the potential U.S. launch of tivozanib, AVEO’s vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) drug candidate, as a treatment for relapsed or refractory RCC. U.S. sales leadership, sales training, marketing, market access and medical affairs teams as well as distribution capabilities are now in place. Hiring, training, and deployment of the Company’s field sales organization is on track for completion ahead of the U.S. Food and Drug Administration’s (FDA) New Drug Application Prescription Drug User Fee Act target action date for tivozanib of March 31, 2021.
Relapsed/Refractory RCC Disease Awareness Website Launched for U.S. Healthcare Professionals. The Company reported the recent launch of www.ReimagineRCC.com, a relapsed/refractory RCC disease awareness resource for U.S. healthcare professionals highlighted by the headline: "After multiple prior treatments in renal cell carcinoma (RCC), the journey can quickly become a challenge". The website highlights the need for more robust data and better tolerated treatment options to support the roughly half of patients who receive second line therapy yet do not continue therapy beyond progression.
Corporate Updates

Updated IP Strategy Offers Potential for Tivozanib Patent Term Extension to November 2028. AVEO holds an exclusive license to two issued U.S. patents for tivozanib, one pertaining to the tivozanib composition of matter, which expires in April 2022, and the other pertaining to a crystalline form of tivozanib, which expires in November 2023. A patent term extension of up to five years may be available under the Hatch-Waxman Act, although only one patent can be extended under the Act. The Company currently intends to file applications for patent term extension on both patents in parallel to provide optionality in its exclusivity strategy. Depending upon which patent the Company ultimately chooses to extend, if a full five year extension is granted for such patent, tivozanib’s exclusivity period could reach either April 2027 or November 2028.
Corinne D. Epperly, MD, MPH Appointed to Board of Directors. AVEO reported the appointment of Corinne D. Epperly, MD, MPH, to its Board of Directors. Dr. Epperly brings over 15 years of experience in oncology as a physician and scientist, blending medicine and business with a proven track record in oncology drug development and launches, commercial and medical strategy, marketing, M&A, and operations gained at Iovance Biotherapeutics, VBL Therapeutics, Bristol Myers Squibb, Goldman Sachs, and the National Cancer Institute of the NIH.
Tivozanib Immuno-Oncology Updates

Results from Phase 1b/2 TiNivo Study of Tivozanib in Combination with OPDIVO (nivolumab) in RCC Published in Annals of Oncology. In November 2020, AVEO announced that previously reported results from the Phase 1b/2 TiNivo study of oral (PO) tivozanib (FOTIVDA) in combination with intravenous (IV) nivolumab (OPDIVO, Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced RCC, were published in Annals of Oncology. The article, titled "TiNivo: Safety and Efficacy of Tivozanib-Nivolumab Combination Therapy in Patients with Metastatic Renal Cell Carcinoma", is available online first via this link. AVEO plans to detail next steps in its investigations of the tivozanib-nivolumab combination following potential FDA approval of tivozanib.
Results from the Phase 1b Portion of DEDUCTIVE Study to Be Presented Friday, January 15, 2021, at ASCO (Free ASCO Whitepaper) GI Cancer Symposium. AVEO is also studying tivozanib in combination with IMFINZI (durvalumab), AstraZeneca’s human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in patients with first line metastatic hepatocellular carcinoma in the Phase 1b/2 DEDUCTIVE clinical trial, which is currently in Phase 2, with enrollment expected to complete this year. Results from the Phase 1b portion of the DEDUCTIVE study are expected to be presented at on Friday, January 15, 2021, at 8:00 am ET, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium.
Ficlatuzumab Update

Enrollment Complete in Phase 2 Open Label Randomized Study of Ficlatuzumab in HNSCC; Results Expected to Be Presented at a Medical Meeting in Mid-2021; Phase 3 Decision on Track for Mid-2021. The Company announced today that enrollment is now complete in its randomized confirmatory Phase 2 study of ficlatuzumab as a single agent or in combination with cetuximab, an EGFR-targeted antibody, in metastatic HNSCC patients who have failed prior immunotherapy, chemotherapy and cetuximab (ERBITUX). Ficlatuzumab is AVEO’s potent hepatocyte growth factor (HGF) inhibitor antibody which binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. The study was designed to confirm findings from a Phase 1/2 study of ficlatuzumab and cetuximab where the combination was well tolerated and resulted in a disease control rate of 67%, as well as prolonged progression-free survival (PFS) and overall survival (OS) compared to historical controls.

Results from the Phase 2 study are expected to be presented at a medical meeting in mid-2021. In that timeframe, the Company plans to announce a Phase 3 decision for ficlatuzumab. In September 2020, AVEO regained full global rights to ficlatuzumab and has initiated clinical manufacture of ficlatuzumab to supply a potential Phase 3 clinical trial in HNSCC, as well as additional potential Phase 2 studies in pancreatic cancer and acute myeloid leukemia.
AV-380 Update

Phase 1 Clinical Study Initiated Following U.S. FDA Acceptance of IND Filing. The Company announced today that its investigational New Drug Application (IND) application for AV-380, its first-in-class, potent, humanized inhibitory antibody targeting GDF15, for the treatment of cancer cachexia, has been accepted by the FDA. Cachexia, a common complication in patients with advanced cancer and other chronic diseases, is a complex metabolic syndrome characterized by malnutrition and severe involuntary weight loss due to the loss of muscle and fat tissue, as well as the clinical manifestation of anemia, inflammation and suppression of immune functions. A Phase 1 study in healthy subjects has been initiated.
About Tivozanib (FOTIVDA)

Tivozanib is an oral, once-daily, next-generation VEGFR TKI discovered by Kyowa Kirin Co. and approved as FOTIVDA for the treatment of adult patients with advanced RCC in the European Union and other countries in the territory of the Company’s partner, EUSA Pharma (UK) Limited (EUSA territory). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for adult patients with relapsed or refractory advanced RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC.4 Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers. Tivozanib is also being studied by partner Kyowa Kirin Co. in non-oncology indications.

On January 7, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that the Company will participate in the J.P. Morgan 39th Annual Healthcare Conference on Thursday, January 14, 2021 at 5:20 p.m. ET (Press release, BeiGene, JAN 7, 2021, View Source [SID1234573649]).

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A live webcast can be accessed from the investors section of BeiGene’s website at View Source or View Source An archived replay will be available for 90 days following the event.

On January 7, 2021 Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer and pre|CISION platforms, reported that it has entered into a license agreement with POINT Biopharma Inc. ("POINT"), to provide access to Avacta’s pre|CISION technology for the development of tumour-activated radiopharmaceuticals (Press release, Avacta, JAN 7, 2021, View Source [SID1234573648]).

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The radiopharmaceutical market is expected to grow to $15 billion by 20251 and there is a substantial opportunity to grow much faster if safety and tolerability of these effective treatments can be improved. POINT Biopharma is a clinical-stage pharmaceutical company focused on developing radioligands2 as precision medicines for the treatment of cancer.

Avacta’s proprietary pre|CISION chemistry can be used to modify a radioligand drug to form a tumour-activated prodrug. The prodrug form is inactive in circulation until it enters the tumour micro-environment where it is activated by an enzyme called fibroblast activation protein (or FAP) that is present in high abundance in most solid tumours but not in healthy tissue. Avacta’s pre|CISION technology therefore has the potential to improve the tolerability and achieve better clinical outcomes for patients compared with standard radiopharmaceuticals by targeting the radioligand treatment more specifically to cancer cells.

The agreement provides POINT with an exclusive license to the pre|CISION technology for use in the first radiopharmaceutical prodrug the company intends to develop, and a non-exclusive license to the pre|CISION platform for the development of a broader pipeline of FAP-activated radiopharmaceuticals.

Under the terms of the agreement, Avacta will receive an upfront fee and development milestones for the first radiopharmaceutical prodrug totaling $9.5 million. Avacta will also receive milestone payments for subsequent radiopharmaceutical prodrugs of up to $8 million each, a royalty on sales of FAP-activated radiopharmaceuticals by POINT and a percentage of any sublicensing income received by POINT.

Alastair Smith, Chief Executive Officer of Avacta Group, commented: "I am very pleased to have established this partnership with POINT that allows Avacta to exploit its pre|CISION platform in a therapeutic area outside of our in-house focus on chemotherapy prodrugs.

The clinical and commercial rationale for our pre|CISION prodrug platform is to improve the safety and efficacy of many existing drugs, as well as generating a pipeline of new and novel cancer therapies. In oncology, we believe that this approach will result in better response rates for monotherapies, and a greater safety margin, to enable their use with a larger patient population and as part of combination therapies.

The in-house development of AVA6000 Pro-doxorubicin, the first of our pre|CISION chemotherapy prodrugs for which we have recently submitted a CTA filing in the UK to begin clinical trials in 2021, has already generated significant interest and this is highlighted by the agreement with POINT announced today.

The potential of the pre|CISION platform to significantly improve outcomes for patients treated with existing cancer therapies through improved safety, tolerability and dosing regimens is enormous. In addition, Avacta is combining the pre|CISION technology with the Affimer platform to create an entirely new class of proprietary TMAC drug conjugates.

I look forward to updating the market on further progress on these and the diagnostic programmes across the Group in the near term."

On January 7, 2021 Pacira BioSciences, Inc. (Nasdaq: PCRX), the leading provider of innovative non-opioid pain management options, reported preliminary unaudited net revenue of $429.6 million for 2020, a 2.0% increase compared with net revenue of $421.0 million reported for 2019 (Press release, Pacira Pharmaceuticals, JAN 7, 2021, View Source [SID1234573646]). The company’s total revenues include net product sales of EXPAREL and iovera°, which were $125.3 million and $2.4 million for the fourth quarter of 2020 and $46.5 million and $0.6 million for the month of December 2020, respectively. EXPAREL average daily sales were 112 percent, 103 percent, and 111 percent of the prior year for the months of October, November, and December, respectively.

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"We are pleased with the solid performance EXPAREL delivered in 2020, with the fourth quarter and full-year 2020 posting record product sales despite ongoing pandemic-related challenges. EXPAREL weekly sales growth continues to outperform the elective surgery market, which we attribute to its critical role in reducing or eliminating the need for opioids and enabling the shift of complex surgical procedures to the 23-hour stay environment. EXPAREL utilization also continues to grow in non-elective procedures, such as cesarean section, oncology, and cardiothoracic surgeries. As we look forward to 2021, the deployment of COVID-19 vaccinations should further support the recovery of elective surgery volumes. EXPAREL remains well positioned for more robust growth as it plays a critical role in revolutionizing the practice of regional anesthesia and enables the ongoing migration of procedures to the ambulatory setting." said Dave Stack, chairman and chief executive officer of Pacira BioSciences.

2020 Full Year & Fourth Quarter Revenue Highlights

Fourth quarter net product sales of EXPAREL/bupivacaine liposome injectable suspension were $127.3 million in 2020, compared to $118.6 million in 2019.
Fourth quarter EXPAREL net product sales were $125.3 million in 2020, compared to $116.9 million in 2019. Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $2.0 million in 2020, compared to $1.7 million in 2019.
Full-year EXPAREL net product sales were $413.3 million in 2020, compared to $407.9 million in 2019. Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $4.5 million in 2020, compared to $3.2 million in 2019.
Full-year iovera° net product sales were $8.8 million in 2020, compared to $7.9 million in 2019. Pacira began recognizing sales of iovera° in April 2019 after completing its acquisition of MyoScience, Inc., a privately held medical technology company.
Fourth quarter royalty revenue was $1.2 million and full-year was $3.0 million in 2020; compared to $0.6 million and $2.1 million in 2019, respectively.
The company’s 2020 product sales were negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the company’s fourth quarter and full-year 2020 financial results. Pacira expects to report its complete financial results for the fourth quarter and full-year 2020 in the first quarter of 2021.

About Pacira BioSciences

Pacira BioSciences, Inc. (Nasdaq: PCRX) is the leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving outcomes for health care practitioners and their patients. The company’s long-acting local analgesic, EXPAREL (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

About EXPAREL

EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

Important Safety Information for Patients

EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies where EXPAREL was injected into the wound, the most common side effects were nausea, constipation, and vomiting. In studies where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. EXPAREL is not recommended to be used in patients younger than 18 years old or in pregnant women. Tell your healthcare provider if you have liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from your body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL: can affect your nervous system and your cardiovascular system; may cause an allergic reaction; may cause damage if injected into your joints.

About iovera°

The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system’s "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue.

Important Safety Information

The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud’s disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.